Back to resultsRenal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial (SymplicityHF)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Renal Impairment
Eligibility Criteria
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
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
Sites / Locations
- Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
Renal Denervation
Outcomes
Primary Outcome Measures
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Secondary Outcome Measures
Ventricular function as measured by Echocardiography
Renal function as measured by Glomerular Filtration Rate (GFR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01392196
Brief Title
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
Acronym
SymplicityHF
Official Title
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
No evidence of a physiological response; no significant safety concerns; post 24-month follow-up; Data Monitoring Committee agreed
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Arm Description
Renal Denervation
Intervention Type
Procedure
Intervention Name(s)
Renal Denervation
Intervention Description
Renal Denervation using the Symplicity Catheter in Heart Failure Population
Primary Outcome Measure Information:
Title
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Ventricular function as measured by Echocardiography
Time Frame
6 month
Title
Renal function as measured by Glomerular Filtration Rate (GFR)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Krum, MD
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
We'll reach out to this number within 24 hrs