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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01705080
Registration number
NCT01705080
Ethics application status
Date submitted
19/09/2012
Date registered
12/10/2012
Date last updated
27/05/2021
Titles & IDs
Public title
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
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Scientific title
IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN
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Secondary ID [1]
0
0
1201
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Universal Trial Number (UTN)
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Trial acronym
EnligHTN-II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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0
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Blood Pressure
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0
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Condition category
Condition code
Cardiovascular
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0
0
0
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Hypertension
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - EnligHTN
A - EnligHTN for Severe Resistant HTN - Office systolic Blood Pressure =160 mmHg
Subject is taking =3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Patient has an estimated GFR =45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
B - EnligHTN for Resistant HTN - Office systolic Blood Pressure =140 mmHg
Subject is taking =3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Patient has an estimated GFR =45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
C - EnligHTN for Resistant HTN & CKD - Office systolic Blood Pressure =140 mmHg
Subject is taking =3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs.
Patient has an estimated =15 GFR <45 mL/min per 1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) formula
Treatment: Devices: EnligHTN
Renal artery ablation with EnligHTN system used for all groups
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Intervention code [1]
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0
Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months
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Assessment method [1]
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0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [1]
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Baseline to 6 months
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Secondary outcome [1]
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0
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure
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Assessment method [1]
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The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.
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Timepoint [1]
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0
30 days post procedure
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Secondary outcome [2]
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Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months
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Assessment method [2]
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The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months
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Assessment method [3]
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Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
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Timepoint [3]
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Confirmatory visit to 6 months
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Secondary outcome [4]
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Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years
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Assessment method [4]
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The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
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Timepoint [4]
0
0
2 years
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Secondary outcome [5]
0
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Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years
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Assessment method [5]
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0
The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.
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Timepoint [5]
0
0
5 years
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Secondary outcome [6]
0
0
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years
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Assessment method [6]
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Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
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Timepoint [6]
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0
Confirmatory visit to 2 years
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Secondary outcome [7]
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0
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years
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Assessment method [7]
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Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.
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Timepoint [7]
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0
Confirmatory visit to 5 years
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Secondary outcome [8]
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Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months
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Assessment method [8]
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24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [8]
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0
Baseline to 6 months
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Secondary outcome [9]
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0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months
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Assessment method [9]
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0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [9]
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0
Baseline to 6 months
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Secondary outcome [10]
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Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months
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Assessment method [10]
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Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [10]
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Baseline to 6 months
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Secondary outcome [11]
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Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months
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Assessment method [11]
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The percentage of participants achieved office systolic blood pressure <140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure <140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.
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Timepoint [11]
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0
6 months
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Secondary outcome [12]
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Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation
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Assessment method [12]
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0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [12]
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0
Baseline to 1 year
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Secondary outcome [13]
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Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation
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Assessment method [13]
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0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [13]
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0
Baseline to 2 years
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Secondary outcome [14]
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0
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation
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Assessment method [14]
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0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [14]
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0
Baseline to 3 years
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Secondary outcome [15]
0
0
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation
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Assessment method [15]
0
0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [15]
0
0
Baseline to 4 years
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Secondary outcome [16]
0
0
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation
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Assessment method [16]
0
0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [16]
0
0
Baseline to 5 years
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Secondary outcome [17]
0
0
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
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Assessment method [17]
0
0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [17]
0
0
Baseline to 1 year
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Secondary outcome [18]
0
0
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
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Assessment method [18]
0
0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [18]
0
0
Baseline to 2 years
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Secondary outcome [19]
0
0
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
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Assessment method [19]
0
0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [19]
0
0
Baseline to 3 years
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Secondary outcome [20]
0
0
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
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Assessment method [20]
0
0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [20]
0
0
Baseline to 4 years
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Secondary outcome [21]
0
0
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
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Assessment method [21]
0
0
Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.
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Timepoint [21]
0
0
Baseline to 5 years
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Secondary outcome [22]
0
0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation
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Assessment method [22]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [22]
0
0
Baseline to 1 year
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Secondary outcome [23]
0
0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation
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Assessment method [23]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [23]
0
0
Baseline to 2 years
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Secondary outcome [24]
0
0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation
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Assessment method [24]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [24]
0
0
Baseline to 3 years
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Secondary outcome [25]
0
0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation
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Assessment method [25]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [25]
0
0
Baseline to 4 years
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Secondary outcome [26]
0
0
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation
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Assessment method [26]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [26]
0
0
Baseline to 5 years
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Secondary outcome [27]
0
0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation
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Assessment method [27]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [27]
0
0
Baseline to 1 year
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Secondary outcome [28]
0
0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation
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Assessment method [28]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Query!
Timepoint [28]
0
0
Baseline to 2 years
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Secondary outcome [29]
0
0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation
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Assessment method [29]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [29]
0
0
Baseline to 3 years
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Secondary outcome [30]
0
0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation
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Assessment method [30]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
Query!
Timepoint [30]
0
0
Baseline to 4 years
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Secondary outcome [31]
0
0
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation
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Assessment method [31]
0
0
24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.
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Timepoint [31]
0
0
Baseline to 5 years
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Eligibility
Key inclusion criteria
- Subject is = 18 years of age at time of consent
- Subject must be able and willing to provide written informed consent
- Subject must be able and willing to comply with the required follow-up schedule
- Subject has office Systolic Blood Pressure = 140 mmHg at confirmatory visit
- Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90
days prior to procedure
- Subject has established hypertension (diagnosed =12 month prior to baseline) and is on
a guideline based drug regimen at a stable and fully tolerated dose consisting of = 3
anti-hypertensive medications (including 1 diuretic) or subject has a documented drug
intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB,
Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3
anti-hypertensive drugs.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
- Subject has undergone prior renal angioplasty, renal denervation, indwelling renal
stents, and/or abdominal aortic stent grafts
- Subject has hemodynamically significant valvular heart disease as determined by study
investigator
- Subject has a life expectancy less than 12 months, as determined by the Investigator
- Subject is participating in another clinical study which has the potential to impact
their hypertension management (pharmaceutical/device/homeopathic)
- Subject is pregnant, nursing, or of childbearing potential and is not using adequate
contraceptive methods
- Subject has active systemic infection
- Subject has renal arteries with diameter(s) < 4 mm in diameter
- Subject has an estimated GFR <15 mL/min per 1.73 m^2 using the MDRD formula
- Subject had a renal transplant or is awaiting a renal transplant
- Subject has blood clotting abnormalities
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/11/2019
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Sample size
Target
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Accrual to date
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Final
276
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
0
0
Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
0
0
The Prince Charles Hospital - Chermside
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Recruitment hospital [3]
0
0
Royal Melbourne Hospital - City Campus - Parkville
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Recruitment hospital [4]
0
0
Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
0
0
5000 - Adelaide
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Recruitment postcode(s) [2]
0
0
4032 - Chermside
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Recruitment postcode(s) [3]
0
0
3050 - Parkville
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Recruitment postcode(s) [4]
0
0
6000 - Perth
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Recruitment outside Australia
Country [1]
0
0
France
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State/province [1]
0
0
Franche-Comte
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Country [2]
0
0
France
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State/province [2]
0
0
Massy
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Country [3]
0
0
France
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State/province [3]
0
0
Lyon
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Country [4]
0
0
France
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State/province [4]
0
0
St. Etienne
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Country [5]
0
0
France
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State/province [5]
0
0
Strasbourg
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Country [6]
0
0
Germany
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State/province [6]
0
0
Bavaria
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Country [7]
0
0
Germany
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State/province [7]
0
0
Hesse
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Country [8]
0
0
Germany
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State/province [8]
0
0
Nordrhein Westfalen
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Country [9]
0
0
Germany
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State/province [9]
0
0
Saxony
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Country [10]
0
0
Germany
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State/province [10]
0
0
Bad Krozingen
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Country [11]
0
0
Germany
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State/province [11]
0
0
Berlin
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Country [12]
0
0
Germany
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State/province [12]
0
0
Essen
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Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Homburg
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Germany
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Mainz
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Germany
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Trier
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Greece
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Athens
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Italy
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Tuscany
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Italy
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Bologna
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Italy
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Milano
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Netherlands
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Den Haag
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Netherlands
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Utrecht
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New Zealand
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Dunedin
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Norway
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Bergen
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Norway
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Trondheim
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Spain
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Basque
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Sweden
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Goteborg
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United Kingdom
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London
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Summary
Brief summary
The purpose of this post market clinical investigation is to further evaluate the safety and
performance of the EnligHTN™ Renal Denervation System in the treatment of patients with
uncontrolled hypertension.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01705080
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Public notes
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Contacts
Principal investigator
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Melvin Lobo, MBChB PhD
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NIHR Barts Cardiovascular Biomedical Research Unit
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01705080
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