Renal Denervation in Patients With Advanced Heart Failure

Heart Failure Clinical Trial

Official title:

Phase 3 Study of Renal Denervation That Improves Symptoms of Heart Failure and Enhances Life Quality in Advanced Heart Failure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01538992
• Other study ID #: Bursa YIEAH
• Status: Withdrawn
• Phase: Phase 3
• First received: February 16, 2012
• Last updated: July 23, 2013
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2013
• Source: Bursa Postgraduate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Standard steerable Marinr RF ablation Catheter (5F or 7F)
Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)

Locations

Country	Name	City	State
Turkey	Bursa Yüksek Ihtisas Egitim ve Arastirma Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Postgraduate Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events		6 months	Yes
Secondary	• 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	Yes