- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01169493
Pacing Affects Cardiovascular Endpoints in Patients With Right Bundle-Branch Block (The PACE-RBBB Trial) (PACE-RBBB)
2016년 8월 1일 업데이트: Duke University
Heart failure (HF) affects 5 million Americans and is responsible for more health-care expenditure than any other medical diagnosis.
Approximately half of all HF patients have electrocardiographic prolongation of the QRS interval and ventricular dyssynchrony, a perturbation of the normal pattern of ventricular contraction that reduces the efficiency of ventricular work.
Ventricular dyssynchrony is directly responsible for worsening HF symptomatology in this subset of patients.
Resynchronization of ventricular contraction is usually achieved through simultaneous pacing of the left and right ventricles using a biventricular (BiV) pacemaker or implantable cardioverter-defibrillator.
Clinical trial evidence supporting the use of BiV pacing in patients with prolonged QRS duration was obtained almost exclusively in patients with a left bundle-branch block (LBBB) electrocardiographic pattern.
Recent evidence suggests that resynchronization of ventricular contraction in patients with LBBB can be obtained by univentricular left ventricular pacing with equal or superior clinical benefits compared to BiV pacing.
Animal studies suggest that ventricular resynchronization can be obtained in subjects with right bundle-branch block (RBBB) through univentricular right ventricular pacing.
No clinical trial evidence exists to support the use of BiV pacing in patients with RBBB.
Thousands of patients with symptomatic HF and RBBB currently have univentricular ICDs in place for the prevention of sudden cardiac death.
Most of these devices are currently programmed to avoid RV pacing.
We aim to determine if ventricular resynchronization delivered through univentricular RV pacing improves symptoms in patients with RBBB and moderate to severe HF who have previously undergone BiV ICD implantation for symptomatic heart failure.
We further aim to determine if ventricular resynchronization improves myocardial performance and ventricular geometry as detected by echocardiographic measures and quality of life for patients with HF and RBBB.
We hypothesize that RV univentricular pacing delivered with an atrio-ventricular interval that maximizes ventricular synchrony is equivalent to BiV pacing for improvement in cardiac performance, HF symptoms, and positive ventricular remodeling in patients with HF and RBBB.
연구 개요
연구 유형
중재적
등록 (실제)
16
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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Durham, North Carolina, 미국, 27710
- Durham VA Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Cardiomyopathy of either idiopathic or ischemic etiology
- NYHA class III, or IV symptoms
- Sinus rhythm
- QRS complex duration > 130 msec in ≥ 2 surface ECG leads with RBBB
- PR interval > 150 msec and < 240 msec
- Prior implantation of dual chamber BiV ICD with apical RV lead location
Exclusion Criteria:
- Myocardial infarction, major surgical procedure, or acute cardiac failure crisis requiring inotropes within 6 months of entry into the study
- Atrial fibrillation or flutter lasting >12 hours within the last 6 months
- Sick sinus syndrome, complete heart block, or other arrhythmias requiring pacemaker support
- Pregnancy
- Any other known condition other than heart failure that could limit exercise time or survival to < 6 months
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: VVI-40 to RV DDD-40 to Bi-V DDD-40
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
|
실험적: VVI-40 to Bi-V DDD-40 to RV DDD-40
Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
|
실험적: Bi-V DDD-40 to VVI-40 to RV DDD-40
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
|
실험적: Bi-V DDD-40 to RV DDD-40 to VVI-40
Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
|
실험적: RV DDD-40 to VVI-40 to Bi-V DDD-40
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
|
실험적: RV DDD-40 to Bi-V DDD-40 to VVI-40
Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40
|
Pacing mode set to VVI-40, RV only pacing
ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
ICD programmed to BiV pacing at a lower rate of 40
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
The Primary Endpoint of the Trial Will be a Comparison of the Proportion of Patients in Each of the Three Treatment Groups Who Demonstrate Positive LV Remodeling, Defined as a Decrease in LV End Systolic Diameter of >5mm.
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
좌심실 박출률(LVEF)
기간: 6 개월
|
6 개월
|
|
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Secondary Echocardiographic Endpoints
기간: 6 months
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Comparisons of the derived velocity-time integral calculated on the aortic continuous wave Doppler-spectrogram, RV end-diastolic size, RV EF, mitral and tricuspid regurgitation severity, and estimated RV systolic pressure.
|
6 months
|
|
Arrhythmic Events
기간: 6 months
|
To determine if pacing mode impacts the frequency of ventricular arrhythmias, the incidence of ventricular tachyarrhythmia episodes on device interrogation will be compared between treatment group assignments.
An episode will be considered ventricular arrhythmia if it lasts longer than 30 seconds or requires anti-tachycardia pacing or high voltage device therapy for termination.
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6 months
|
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Minnesota Quality of Life Questionnaire
기간: 6 months
|
This is a standardized method for assessing quality of life in patients with heart failure.
It asks 21 questions and measures the impact HF has on a subject's life.
Each question is rated 0-5.
The total score for the 21 items can range from 0 to 105.
Higher scores indicate more burden of disease on quality of life.
|
6 months
|
|
6-minute Walk Distance
기간: 6 months
|
6-minute walk distance was the distance that a participant could walk in 6 minutes.
|
6 months
|
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NYHA Function Class
기간: 6 months
|
The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity.
Class I means there is no limitation of physical activity and Class IV means a person is unable to carry on any physical activity without discomfort/symptoms of heart failure at rest.
|
6 months
|
|
Left Ventricular End-diastolic Size
기간: 6 months
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6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 1월 1일
기본 완료 (실제)
2014년 8월 1일
연구 완료 (실제)
2014년 8월 1일
연구 등록 날짜
최초 제출
2010년 7월 22일
QC 기준을 충족하는 최초 제출
2010년 7월 22일
처음 게시됨 (추정)
2010년 7월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 9월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 8월 1일
마지막으로 확인됨
2016년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Pro00025144
- 10CRP3630033 (기타 보조금/기금 번호: American Heart Association)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .