Renal Denervation in Patients With Advanced Heart Failure

Phase 3

Withdrawn

• Conditions: Heart Failure
• Interventions: Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)

• Registration Number: NCT01538992
• Lead Sponsor: Bursa Postgraduate Hospital

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

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-27
• Study Start: 2013-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-23
• Last Update Posted: 2013-07-24
• Primary Completion: 2014-01
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
renal denervation	Standard steerable Marinr RF ablation Catheter (5F or 7F)	in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)

Primary Outcome Measures

Name	Time	Method
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events	6 months

Secondary Outcome Measures

Name	Time	Method
• 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

Trial Locations

Locations (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi; 🇹🇷 Bursa, Turkey