Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Bursa Postgraduate Hospital
- Locations
- 1
- Primary Endpoint
- Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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
Investigators
Hasan ARI
Medical Doctor, Cardiology Chief Intern
Bursa Postgraduate Hospital
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.
Outcomes
Primary Outcomes
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Time Frame: 6 months
Secondary Outcomes
- • Ventricular function as measured by Echocardiography • NYHA functional Class, 6 min walking test, biochemical test. • Renal function as measured by Glomerular Filtration Rate (GFR)(6 months)