Renal Artery Denervation in Chronic Heart Failure Study (REACH)

Imperial College London

Status and phase: Unknown; Phase 3

Conditions: Chronic Systolic Heart Failure

Treatments: Procedure: Renal Denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01639378

REACH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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%

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Subjects are treated with renal denervation after randomisation and maintained on heart failure medications

Treatment:

Procedure: Renal Denervation

Control group

No Intervention group

Description:

Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications