Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01392196




Registration number
NCT01392196
Ethics application status
Date submitted
7/07/2011
Date registered
12/07/2011
Date last updated
1/02/2017

Titles & IDs
Public title
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
Scientific title
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
Secondary ID [1] 0 0
TP085
Universal Trial Number (UTN)
Trial acronym
SymplicityHF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
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: Surgery - Renal Denervation

Other: Single arm - Renal Denervation


Treatment: Surgery: Renal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Timepoint [1] 0 0
6 month
Secondary outcome [1] 0 0
Ventricular function as measured by Echocardiography
Timepoint [1] 0 0
6 month
Secondary outcome [2] 0 0
Renal function as measured by Glomerular Filtration Rate (GFR)
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* Heart Failure patients NYHA Class II or III
* Renal Impairment Left Ventricular Ejection Function <40%
* GFR 30 to 75 mL/min/1.73m2
* Optimal stable medical therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Renal artery anatomy must be eligible for treatment as determined by Angiography, and
* History of prior renal artery intervention
* Single functioning kidney.
* Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
* Systolic BP < 90 mmHG

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Vascular
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MD
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01392196