Renal Artery Denervation in Chronic Heart Failure Study (REACH)
Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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London, 영국, W2 1LA
- Imperial College London
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Renal Denervation
Subjects are treated with renal denervation after randomisation and maintained on heart failure medications
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Symplicity Catheter System
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간섭 없음: Control group
Subject will have a sham procedure and not receive renal denervation.
They will continue with the heart failure medications
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improvement in symptomatology
기간: Baseline to 12 months post-randomization
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Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
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Baseline to 12 months post-randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improvement in peak VO2 on cardiopulmonary exercise testing
기간: Baseline to 12 months post-randomization
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The peak VO2 will be compared in the interventional against the sham arm
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Baseline to 12 months post-randomization
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Improvement in self-paced exercise distance
기간: Baseline to 12 months post-randomization
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Improvement in 6 min walk to in interventional arm compared to sham arm
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Baseline to 12 months post-randomization
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Change in chemoreflex sensitivity
기간: Baseline to 12 months post-randomization
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Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm
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Baseline to 12 months post-randomization
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Change in NYHA functional classification
기간: Baseline to 12 months post-randomization
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Assess the change in NYHA in interventional arm in comparison to sham arm
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Baseline to 12 months post-randomization
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Incidence of Major Adverse Events
기간: Baseline to 12 months post-randomization
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The incidence of major adverse events will be compared in the interventional against the sham arm
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Baseline to 12 months post-randomization
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공동 작업자 및 조사자
수사관
- 연구 책임자: Darrel P Francis, BA, MD, Imperial College London
- 수석 연구원: Justin E Davies, MBBS, PHD, Imperial College London
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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