Back to resultsRenal Denervation in Patients With Advanced Heart Failure
Primary Purpose
Heart Failure
Status
Withdrawn
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Standard steerable Marinr RF ablation Catheter (5F or 7F)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring renal denervation, heart failure
Eligibility Criteria
Inclusion Criteria:
- Heart Failure patients NYHA Class III or IV
- Left Ventricular Ejection Function < 35%
- GFR > 45 mL/min/1.73m2
- Optimal stable medical therapy
Exclusion Criteria:
- Do not eligible renal artery anatomy 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 < 110mmHG Hospitalisation because of heart failure in last 3 weeks.
Sites / Locations
- Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
renal denervation
medical thrapy
Arm Description
in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)
medical treatment
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 • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)
Full Information
NCT ID
NCT01538992
First Posted
February 16, 2012
Last Updated
July 23, 2013
Sponsor
Bursa Postgraduate Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01538992
Brief Title
Renal Denervation in Patients With Advanced Heart Failure
Official Title
Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Why Stopped
we could not fined enough patients for the study
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Postgraduate Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sympathetic system has important role occurrence of symptoms in heart failure. Renal denervation that is ablated some of sympathetic nerves is affected pathology of heart failure. This interventional therapy improves symptoms and life quality.
Detailed Description
Primary Outcome Measures:
• Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Secondary Outcome Measures:
• Ventricular function,NYHA functional Class, 6 min walking test, biochemical test and Renal function as measured by Glomerular Filtration Rate (GFR)
Eligibility Patients population: Volunteers, NYHA Class III-IV heart failure patients. Ages Eligible for Study: 18 Years to 85 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
renal denervation, heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
renal denervation
Arm Type
Experimental
Arm Description
in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)
Arm Title
medical thrapy
Arm Type
No Intervention
Arm Description
medical treatment
Intervention Type
Device
Intervention Name(s)
Standard steerable Marinr RF ablation Catheter (5F or 7F)
Other Intervention Name(s)
Renal ablation
Intervention Description
Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)
Primary Outcome Measure Information:
Title
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
• Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart Failure patients NYHA Class III or IV
Left Ventricular Ejection Function < 35%
GFR > 45 mL/min/1.73m2
Optimal stable medical therapy
Exclusion Criteria:
Do not eligible renal artery anatomy 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 < 110mmHG Hospitalisation because of heart failure in last 3 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HASAN ARI, MD
Organizational Affiliation
Bursa Postgraduate Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
City
Bursa
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Renal Denervation in Patients With Advanced Heart Failure
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