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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Subjects are treated with renal denervation after randomisation and maintained on heart failure medications |
|
| Control group | No Intervention | Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation | Procedure | Symplicity Catheter System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in symptomatology | Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire | Baseline to 12 months post-randomization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrel P Francis, BA, MD | Imperial College London | Study Director |
| Justin E Davies, MBBS, PHD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | W2 1LA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22392370 | Background | Sobotka PA, Krum H, Bohm M, Francis DP, Schlaich MP. The role of renal denervation in the treatment of heart failure. Curr Cardiol Rep. 2012 Jun;14(3):285-92. doi: 10.1007/s11886-012-0258-x. |
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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 |