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Renal Artery Denervation in Chronic Heart Failure Study (REACH)

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ClinicalTrials.gov Identifier: NCT01639378
Recruitment Status : Unknown
Verified August 2016 by Imperial College London.
Recruitment status was:  Active, not recruiting
First Posted : July 12, 2012
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Chronic Systolic Heart Failure Procedure: Renal Denervation Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
Study Start Date : August 2012
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Renal Denervation
Subjects are treated with renal denervation after randomisation and maintained on heart failure medications
Procedure: Renal Denervation
Symplicity Catheter System

No Intervention: Control group
Subject will have a sham procedure and not receive renal denervation. They will continue with the heart failure medications



Primary Outcome Measures :
  1. Improvement in symptomatology [ Time Frame: Baseline to 12 months post-randomization ]
    Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire


Secondary Outcome Measures :
  1. Improvement in peak VO2 on cardiopulmonary exercise testing [ Time Frame: Baseline to 12 months post-randomization ]
    The peak VO2 will be compared in the interventional against the sham arm

  2. Improvement in self-paced exercise distance [ Time Frame: Baseline to 12 months post-randomization ]
    Improvement in 6 min walk to in interventional arm compared to sham arm

  3. Change in chemoreflex sensitivity [ Time Frame: Baseline to 12 months post-randomization ]
    Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm

  4. Change in NYHA functional classification [ Time Frame: Baseline to 12 months post-randomization ]
    Assess the change in NYHA in interventional arm in comparison to sham arm

  5. Incidence of Major Adverse Events [ Time Frame: Baseline to 12 months post-randomization ]
    The incidence of major adverse events will be compared in the interventional against the sham arm



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639378


Locations
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United Kingdom
Imperial College London
London, United Kingdom, W2 1LA
Sponsors and Collaborators
Imperial College London
Investigators
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Study Director: Darrel P Francis, BA, MD Imperial College London
Principal Investigator: Justin E Davies, MBBS, PHD Imperial College London

Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01639378     History of Changes
Other Study ID Numbers: REACH
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases