Renal Artery Denervation in Chronic Heart Failure Study
REACH
Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2012
CompletedFirst Posted
Study publicly available on registry
July 12, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedNovember 11, 2016
August 1, 2016
4.7 years
July 10, 2012
November 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in symptomatology
Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
Baseline to 12 months post-randomization
Secondary Outcomes (5)
Improvement in peak VO2 on cardiopulmonary exercise testing
Baseline to 12 months post-randomization
Improvement in self-paced exercise distance
Baseline to 12 months post-randomization
Change in chemoreflex sensitivity
Baseline to 12 months post-randomization
Change in NYHA functional classification
Baseline to 12 months post-randomization
Incidence of Major Adverse Events
Baseline to 12 months post-randomization
Study Arms (2)
Renal Denervation
EXPERIMENTALSubjects are treated with renal denervation after randomisation and maintained on heart failure medications
Control group
NO INTERVENTIONSubject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London
London, W2 1LA, United Kingdom
Related Publications (1)
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.
PMID: 22392370BACKGROUND
Study Officials
- STUDY DIRECTOR
Darrel P Francis, BA, MD
Imperial College London
- PRINCIPAL INVESTIGATOR
Justin E Davies, MBBS, PHD
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2012
First Posted
July 12, 2012
Study Start
August 1, 2012
Primary Completion
April 1, 2017
Last Updated
November 11, 2016
Record last verified: 2016-08