Renal Denervation in Patients With Advanced Heart Failure

July 23, 2013 updated by: Hasan ARI, Bursa Postgraduate Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: renal denervation
in this group percutaneous renal denervation with Standard steerable Mariner Radiofreqency ablation Catheter (5F or 7F)
Device: Standard steerable Marinr RF ablation Catheter (5F or 7F)
Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)
Other Names:
  • Renal ablation
NO_INTERVENTION: medical thrapy
medical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
• 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Postgraduate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2014

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (ESTIMATE)

February 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bursa YİEAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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