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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
Symplicity Catheter System
Imperial College London
London, United Kingdom
Improvement in symptomatology
Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
Time frame: Baseline to 12 months post-randomization
Improvement in peak VO2 on cardiopulmonary exercise testing
The peak VO2 will be compared in the interventional against the sham arm
Time frame: 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
Time frame: 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
Time frame: Baseline to 12 months post-randomization
Change in NYHA functional classification
Assess the change in NYHA in interventional arm in comparison to sham arm
Time frame: 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
Time frame: Baseline to 12 months post-randomization
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