Renal Artery Denervation in Chronic Heart Failure Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure

Conditions
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Chronic Systolic Heart Failure

Intervention / Treatment
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* Procedure: Renal Denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Subjects are treated with renal denervation after randomisation and maintained on heart failure medications | Procedure: Renal Denervation<br>* Symplicity Catheter System<br>|
| No Intervention: Control group<br>Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in symptomatology | Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire | Baseline to 12 months post-randomization | 

Secondary Outcome Measures

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