Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- increase of the ejection fraction of the left ventricle
研究概览
简要总结
The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy
详细描述
This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.
The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.
Hypothesis
The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dilated cardiomyopathy according to WHO criteria
- •Syndromic heart failure in functional class III or IV of the NYHA
- •Enrollment and continuous follow-up in cardiac out-patient clinic
- •Adequate medical therapy after optimization therapy
- •Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule
排除标准
- •Valvular diseases, except functional mitral or tricuspid reflow
- •Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
- •Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
- •Sustained ventricular tachycardia
- •Abusive use of alcohol or illicit drugs
- •Pregnancy
- •Use of cardio toxic drugs
- •Any co-morbidity with impact in life expectancy in 2 years
- •Renal function compromised (creatinine above 2 mg/dl)
研究组 & 干预措施
Optimal Therapy
Optimal therapy for cardiac failure
干预措施: optimal therapy for cardiaca failure (Drug)
cell therapy
stem cell
干预措施: cell (Procedure)
结局指标
主要结局
increase of the ejection fraction of the left ventricle
时间窗: 6 months
次要结局
- Death by any cause(1 year)
- Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline(1 year)
- Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire(6 month)
- Difference in NYHA functional class(6 month)
- Percent number of patients that reached an absolute increase of 5% in ejection fraction(1 year)
研究者
Bernardo Rangel Tura
Professor
Ministry of Health, Brazil