Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
N/A
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary
aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe
and determine the evidence of a response to renal denervation in patients with Heart Failure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01392196
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01392196