- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01961726
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Ischemic Heart Failure (RETRO-HF)
A Phase I/II Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Retrograde Delivery to Cohorts of Adults With Ischemic Heart Failure
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35211
- Cardiology, P.C.
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Florida
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Gainsville, Florida, 미국, 32610-0277
- University of Florida
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Ohio
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Cincinnati, Ohio, 미국, 45219
- The Carl and Edyth Lindner Center for Research & Education at The Christ Hospital
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Utah
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Salt Lake City, Utah, 미국, 84132
- University of Utah
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Willing and able to sign informed consent
- Greater than or equal to 18 years of age
- Poor quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)
- Impaired 6 Minute Walk test
- Ischemic cardiomyopathy without an acute coronary syndrome within the last 6 months
- Residual well-demarcated region of LV systolic dysfunction defined as at least 3 consecutive segments of abnormal wall motion by echocardiography read at the echocardiography core laboratory
- LVEF less than or equal to 40% measured by echocardiography read at the echocardiography core laboratory
Subject receiving stable optimal pharmacological therapy defined as:
- ACE inhibitor and/or ARB, and Beta-blocker for 90 days with stable dose* for
- 30 days unless contraindicated
- Diuretic in subjects with evidence of fluid retention
- ASA unless contraindicated
- Statin unless contraindicated
- Aldosterone antagonist per physician discretion
- Subject must not have a permanent device placed in the coronary sinus at the time of enrollment *As defined as no more than 50% change in dose
Exclusion Criteria:
Planned revascularization within 30 days following enrollment
- Note: if an angiographic study has been performed within the last year and the subject is enrolled, the angiography study report should be included as part of the subject's file
- Estimated Glomerular Filtration Rate < 30 ml/min*
- Signs of acute heart failure within 24 hours of scheduled infusion
- History of aortic valve regurgitation classified as "moderate-severe" or worse
Patients will be excluded who have:
- Known prior trauma to the coronary sinus
- In dwelling instrumentation that may hamper coronary venous catheterization, including a biventricular pacing coronary sinus lead
- Mitral regurgitation defined as "severe" measured by echocardiography at the clinical site
- Patients with planned mitral valve repair or replacement surgery
Any patient with a history of cancer will be excluded unless:
- The cancer was limited to curable non-melanoma skin malignancies and/or
- The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence.
Subjects with persistent (per ACC/AHA/EEC guidelines)53, defined as recurrent AF episodes lasting longer than 7 days) or chronic atrial fibrillation will be excluded unless:
- A stable, regular heart rate is maintained with a biventricular pacemaker
- A stable, regular heart rate is maintained with a univentricular pacemaker pacing less than or equal to 40% of the time
- Inability to undergo 6 minute walk or treadmill exercise test
- Previous solid organ transplant
- Subjects with greater than 40% univentricular RV Pacing
- Subjects with uncontrolled diabetes defined as HbA1c >10 %
- Participation in an experimental clinical trial within 30 days prior to enrollment
- Life expectancy of less than 1 year
- Positive pregnancy test (serum βHCG) in women of childbearing potential and/or unwillingness to use contraceptives or limit sexual activity as described in Section 8.2.1 below
- Unwillingness of men capable of fathering a child to agree to use barrier contraception or limit sexual activity as described in Section 8.2.1 below
- Subjects who are breast feeding
Subjects with a positive test results for hepatitis B/C and/or HIV will be excluded unless:
- The subject is a carrier for hepatitis B/C but has never had an active flare
- Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
- Total Serum Bilirubin >4.0 mg/dl
- Aspartate aminotransferase (AST) > 120 IU/L
- Alanine aminotransferase (ALT) > 135 IU/L
- Alkaline phosphatase (ALP): >300 IU/L
- Clinically significant elevations in PT or PTT relative to laboratory norms at day 0
- Critical limb ischemia that limits the patients from completing 6 minute walk or treadmill testing
Subjects with severe chronic obstructive pulmonary disease (COPD)
- Severe defined as having been hospitalized for COPD within the last 12 months
- Any subject requiring home oxygen use for treatment of the symptoms of COPD
- History of drug or alcohol abuse within the last year
- A subject will be excluded if he/she is unfit for the trial based on the discretion of the site Principal Investigator
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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Coronary Sinus Delivery
Coronary Sinus Delivery
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실험적: 30 mg dose of JVS-100
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Coronary Sinus Delivery
Coronary Sinus Delivery
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실험적: 45 mg dose of JVS-100
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Coronary Sinus Delivery
Coronary Sinus Delivery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Impact of JVS-100 delivery on 6 minute walk distance at 4 month follow-up
기간: 4 Months
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To investigate the impact of single doses of JVS-100 (either 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on 6 minute walk distance compared to placebo at 4 months post dosing.
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4 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Impact of JVS-100 delivery on heart failure symptoms compared to placebo at 4 and/or 12 month follow-up
기간: 4 and/or 12 months
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To assess the impact of a single dose of JVS-100 on heart failure symptoms compared to placebo at 4 and/or 12 months post-dosing.
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4 and/or 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Impact of JVS-100 delivery on quality of life measure at 4 month follow-up
기간: 4 Months
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To investigate the impact of single doses of JVS-100 (either 30 or 45 mg) delivered retrograde via the coronary sinus through the Oscor Venos Occlusion Balloon catheter on quality of life measure compared to placebo at 4 months post dosing.
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4 Months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 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
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. .
허혈성 심부전에 대한 임상 시험
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Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University of... 그리고 다른 협력자들아직 모집하지 않음심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
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Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
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University of WashingtonAmerican Heart Association완전한심부전,울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
30 mg dose of JVS-100에 대한 임상 시험
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MedImmune LLC완전한
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Morten LindbaekNorwegian Institute of Public Health; Sorlandet Hospital HF; Norwegian University of Life...완전한라임 병 | 이동성 홍반 | 홍반 Chronicum Migrans | 보렐리아증 | 초기 라임병노르웨이
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Millennium Pharmaceuticals, Inc.Johnson & Johnson Pharmaceutical Research & Development, L.L.C.완전한맨틀 세포 림프종중국, 벨기에, 태국, 미국, 스페인, 캐나다, 콜롬비아, 이탈리아, 모로코, 브라질, 칠면조, 칠레, 말레이시아, 이스라엘, 포르투갈, 싱가포르, 러시아 연방, 필리핀 제도, 튀니지, 오스트리아, 체코, 독일, 헝가리, 인도, 폴란드, 루마니아, 남아프리카, 대만, 우크라이나