Clinical trial NCT01639378: Renal Artery Denervation in Chronic Heart Failure Study
Official title: Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Systolic Heart Failure
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in symptomatology
timeFrame: Baseline to 12 months post-randomization
Secondary outcomes:
measure: Improvement in peak VO2 on cardiopulmonary exercise testing
timeFrame: Baseline to 12 months post-randomization
measure: Improvement in self-paced exercise distance
timeFrame: Baseline to 12 months post-randomization
measure: Change in chemoreflex sensitivity
timeFrame: Baseline to 12 months post-randomization
measure: Change in NYHA functional classification
timeFrame: Baseline to 12 months post-randomization
measure: Incidence of Major Adverse Events
timeFrame: Baseline to 12 months post-randomization
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College London
name: Darrel P Francis, BA, MD
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Justin E Davies, MBBS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.