Renal Artery Denervation in Chronic Heart Failure Study

Phase 3

• Conditions: Chronic Systolic Heart Failure
• Interventions: Procedure: Renal Denervation

• Registration Number: NCT01639378
• Lead Sponsor: Imperial College London

Brief Summary

The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.

Detailed Description

Interventional study

Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation.

Primary Purpose: Treatment

Chronic Systolic Heart Failure

Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System

-Intervention: Device: Renal denervation (Symplicity Catheter System)

Patients are randomised in the cath lab to receive either renal denervation or sham procedure.

Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure)

In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-12
• Study Start: 2012-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11
• Primary Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Chronic heart failure due to systolic dysfunction
• New York Heart Association class II or higher
• Maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ACE inhibitors /A2 blocker, Aldosterone blockade.
• Ejection fraction less than 40%

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Exclusion Criteria

• Estimated GFR<35ml/hr
• Unfavourable renal anatomy (renal artery stenosis)
• Unable to walk on a treadmill for cardiopulmonary exercise test
• Significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation)
• Severe lung disease
• Symptomatic orthostatic dizziness
• Unable to consent
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation	Subjects are treated with renal denervation after randomisation and maintained on heart failure medications

Primary Outcome Measures

Name	Time	Method
Improvement in symptomatology	Baseline to 12 months post-randomization	Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire

Secondary Outcome Measures

Name	Time	Method
Improvement in peak VO2 on cardiopulmonary exercise testing	Baseline to 12 months post-randomization	The peak VO2 will be compared in the interventional against the sham arm
Improvement in self-paced exercise distance	Baseline to 12 months post-randomization	Improvement in 6 min walk to in interventional arm compared to sham arm
Change in chemoreflex sensitivity	Baseline to 12 months post-randomization	Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm
Change in NYHA functional classification	Baseline to 12 months post-randomization	Assess the change in NYHA in interventional arm in comparison to sham arm
Incidence of Major Adverse Events	Baseline to 12 months post-randomization	The incidence of major adverse events will be compared in the interventional against the sham arm

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom