Chronic Systolic Heart Failure
Conditions
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.
Interventions
PROCEDURERenal Denervation
Symplicity Catheter System
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in symptomatology | Baseline to 12 months post-randomization | Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed