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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/NCT02041130




Registration number
NCT02041130
Ethics application status
Date submitted
28/10/2013
Date registered
20/01/2014
Date last updated
16/01/2015

Titles & IDs
Public title
Renal Denervation in Heart Failure Patients With Preserved Ejection Fraction (RESPECT-HF)
Scientific title
Renal Sympathectomy in Heart Failure (the RESPECT-HF Study) - a Study of Renal Denervation for Heart Failure With Preserved Ejection Fraction
Secondary ID [1] 0 0
DSRB: 2013/00457
Universal Trial Number (UTN)
Trial acronym
RESPECT-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Renal Denervation

Experimental: Renal Denervation and standard medical management - Renal Denervation (RDN) is a simple catheter procedure removing excess nerve signals to and from the kidneys. The renal denervation system consists of a small steerable treatment catheter and an automatically-controlled treatment delivery generator.
A guiding catheter is inserted through a tiny incision in the groin into the femoral artery to direct the treatment catheter to the renal arteries. The treatment catheter delivers high -frequency radio waves, called radiofrequency wavees, to 4-6 locations within each of the two renal arteries. the energy delivered is about 8 watts and aims to disrupt the nerves and lower blood pressure over a period of months. The procedure takes 40-60 minutes.

No Intervention: Contorl and Standard Medical Management - Continued medical management will comprise management of all cardiovascular risk factors (hypertension, diabetes, dyslipidaemia) in accord with international guidelines. Lifestyle and dietary counselling will also be part of the patient management. As there is no established evidence-based pharmacotherapy for HFPEF per se, therapy aimed at HF specifically will adopt treatments recommended for HFREF with prescription of diuretic, ACE inhibitor/ARB, beta blocker and mineralocorticoid antagonist accordingly.


Treatment: Devices: Renal Denervation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare the changes in left atrial volume index (LAVi) and/or left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (cMRI) between baseline and 6 months
Timepoint [1] 0 0
baseline, 6 months
Secondary outcome [1] 0 0
Compare the changes in exercise capacity and functional status as assessed by maximal oxygen consumption (VO2max) on cardiopulmonary exercise testing and by 6-minute walk test between baseline and 6 months
Timepoint [1] 0 0
baseline, 6 months
Secondary outcome [2] 0 0
Compare the changes in chocardiographic grade of diastolic dysfunction as assessed by Tissue Doppler E/e', (a non-invasive estimate of left atrial filling pressure).
Timepoint [2] 0 0
baseline, 6 months
Secondary outcome [3] 0 0
Compare the changes in biomarkers of cardiac load and interstitial fibrosis as assessed by plasma assays of relevant biomarkers
Timepoint [3] 0 0
baseline, 6 months
Secondary outcome [4] 0 0
Compare the changes in ventricular-vascular function as evaluated by echocardiographic measures of arterial elastance, Left Ventricular (LV) end-systolic elastance, LV filling pressure, and LV diastolic stiffness between baseline and 6 months
Timepoint [4] 0 0
baseline, 6 months
Secondary outcome [5] 0 0
Compare the changes of Quality of life as assessed by the Minnesota Living with Heart Failure between baseline and 6 months.
Timepoint [5] 0 0
baseline, 6 months
Secondary outcome [6] 0 0
Compare the difference in composite end-point of death or hospitalization with Heart Failure between control arm and treatment arm
Timepoint [6] 0 0
baseline, 6 months

Eligibility
Key inclusion criteria
1. Patients with HFPEF (based upon ESC diagnostic criteria9)

1. Symptoms and signs of heart failure; NYHA Class II or higher

2. Left ventricular ejection fraction 50% or greater on echocardiography

3. Echocardiographic evidence of left ventricular diastolic dysfunction
(echo-Doppler E/e' > 15 )AND/OR plasma NTproBNP > 220pg/ml.

2. Episode of acute decompensation (ADHF)

3. Patients with and without background hypertension may be recruited. In the case of
patients with background hypertension (ie history of fulfilling the diagnostic WHO
criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg) those with both
controlled (<140/90mmHg by 24 hour ambulatory BP) and inadequately controlled BP (on 3
anti-hypertensive drugs including a diuretic) can be recruited.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known secondary cause of hypertension

2. Renal artery stenosis >30% or anatomy otherwise unsuitable for RDN.

3. Heart failure with reduced LV ejection fraction (LVEF < 50%).

4. Estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2 (MDRD calculation).

5. Systolic blood pressure < 105mmHg.

6. Implanted pacemaker, prosthetic heart valve or other precluding cMR scanning.

7. Medical condition adversely affecting safety and/or effectiveness of the participant
(including peripheral vascular disease, abdominal aortic aneurysm, thrombocytopenia or
atrial fibrillation).

8. Pregnant, nursing or planning to be pregnant.

9. Uncontrolled atrial fibrillation, ie with heart rate over 120 bpm

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2016
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington
Country [4] 0 0
Singapore
State/province [4] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
National University Hospital, Singapore
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Otago
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Wellington Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Auckland, New Zealand
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Monash University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Tan Tock Seng Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Changi General Hospital
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Singapore Clinical Research Institute
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Investigators will test a new approach to a form of heart failure (HF) with no current
treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have
preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These
"stiff" hearts pump strongly but fill inefficiently resulting in poor exercise capacity and
high death rates. Treatments that help when heart pumping action is poor are of no benefit in
HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the
kidneys ("renal denervation"; RDN) has been able to reduce BP in patients with high BP
resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys,
heart and circulation this treatment has promise in HF. The investigators will compare
effects of RDN and standard medical treatment on heart function, exercise capacity and
quality of life in 144 patients with HFPEF
Trial website
https://clinicaltrials.gov/ct2/show/NCT02041130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arthur Mark Richards, MBChB, MD (Distinction), PhD
Address 0 0
University of Otago, Christchurch
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mark Richards Arthur, MBChB, MD (Distinction), PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02041130