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Renal Artery Denervation in Chronic Heart Failure Study (REACH)

Primary Purpose

Chronic Systolic Heart Failure

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Systolic Heart Failure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imperial College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal Denervation

Control group

Arm Description

Subjects are treated with renal denervation after randomisation and maintained on heart failure medications

Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications

Outcomes

Primary Outcome Measures

Improvement in symptomatology
Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire

Secondary Outcome Measures

Improvement in peak VO2 on cardiopulmonary exercise testing
The peak VO2 will be compared in the interventional against the sham arm
Improvement in self-paced exercise distance
Improvement in 6 min walk to in interventional arm compared to sham arm
Change in chemoreflex sensitivity
Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm
Change in NYHA functional classification
Assess the change in NYHA in interventional arm in comparison to sham arm
Incidence of Major Adverse Events
The incidence of major adverse events will be compared in the interventional against the sham arm

Full Information

First Posted
July 10, 2012
Last Updated
November 10, 2016
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT01639378
Brief Title
Renal Artery Denervation in Chronic Heart Failure Study
Acronym
REACH
Official Title
Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Systolic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Subjects are treated with renal denervation after randomisation and maintained on heart failure medications
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications
Intervention Type
Procedure
Intervention Name(s)
Renal Denervation
Intervention Description
Symplicity Catheter System
Primary Outcome Measure Information:
Title
Improvement in symptomatology
Description
Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
Time Frame
Baseline to 12 months post-randomization
Secondary Outcome Measure Information:
Title
Improvement in peak VO2 on cardiopulmonary exercise testing
Description
The peak VO2 will be compared in the interventional against the sham arm
Time Frame
Baseline to 12 months post-randomization
Title
Improvement in self-paced exercise distance
Description
Improvement in 6 min walk to in interventional arm compared to sham arm
Time Frame
Baseline to 12 months post-randomization
Title
Change in chemoreflex sensitivity
Description
Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm
Time Frame
Baseline to 12 months post-randomization
Title
Change in NYHA functional classification
Description
Assess the change in NYHA in interventional arm in comparison to sham arm
Time Frame
Baseline to 12 months post-randomization
Title
Incidence of Major Adverse Events
Description
The incidence of major adverse events will be compared in the interventional against the sham arm
Time Frame
Baseline to 12 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darrel P Francis, BA, MD
Organizational Affiliation
Imperial College London
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Justin E Davies, MBBS, PHD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W2 1LA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22392370
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.
Results Reference
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Renal Artery Denervation in Chronic Heart Failure Study

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