Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 220
- 试验地点
- 35
- 主要终点
- Responder Analysis - Peak Oxygen Uptake (Peak VO2)
研究概览
简要总结
The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm (Treatment group) show statistically significant improvement compared to patients in the optimal medical and device therapy alone arm (Control group) after 6 months of follow-up.
详细描述
In the United States alone, more than five million people suffer from heart failure (CHF) and an estimated 400,000 to 700,000 new cases are diagnosed each year. Caused by a variety of cardiac conditions, systolic heart failire (HF) is the end-stage of heart disease where the heart is failing as a pump. Once diagnosed with the disease, less than 50% of the patients live for five years, and less than 25% survive for more than ten years. The number of deaths in the United States from this condition has more than doubled since 1979, averaging more than 250,000 annually.
Paracor Medical, Inc. has developed an elastic prosthetic wrap that is designed to apply a gentle mechanical support to the failing heart. The Implant is a compliant elastic structure that is designed to conform to the epicardial surface of the right and left ventricles. It supports the heart throughout the cardiac cycle and was designed to offload the ventricles and reduce wall stress.
The objective of this clinical trial is to evaluate the safety and efficacy of the HeartNet Ventricular Support System with optimal medical and device therapy (Treatment group) when compared to optimal medical and device therapy (i.e., medications, cardiac resynchronisation therapy, pacemaker) alone (Control group) as treatments for patients with heart failure.
Efficacy of the HeartNet Ventricular Support System in the Treatment group compared to the optimal medical and device therapy Control group will be evaluated based upon cardiopulmonary tests (Peak VO2), six (6) minute walk distance and quality of life assessment, as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire.
Safety of the HeartNet Ventricular Support System in the Treatment group compared to the Control group will be evaluated based on the all-cause mortality rate.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic heart failure at enrollment (American College of Cardiology [ACC]/American Heart Association [AHA] Stage C) due to ischemic or nonischemic dilated cardiomyopathy
- •On stable, evidence-based medical and device therapy for heart failure for 3 months prior to randomization <a> Pharmacological Therapy (as appropriate) <i> angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB) for patients with ACE inhibitor intolerance or nitrate/hydralazine at the investigators discretion <ii> beta blockers <iii> diuretics, aldosterone inhibitors <b> Ejection fraction < or = to 35% while maintained on optimal medical therapy <c> Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy-Defibrillator (CRT-D) <i> If implanted with a CRT or CRT-D, it must be implanted > or = to 3 months before randomization <ii> If currently eligible or anticipated eligibility with a CRT or CRT-D within 6 months, the patient should not be enrolled in the study
- •Specific Qualifying Characteristics
- •Six (6) minute walk of 150 - 450m
- •Peak VO2 for males: 10.0-20.0 ml/kg/min; Peak VO2 for females: 9.0-18.0 ml/kg/min
- •Left ventricular end diastolic diameter (LVEDD) <85mm and index <40mm/m2 (LVEDD/BSA)
- •Heart failure duration > or = to 6 months
排除标准
- •Patient History
- •Heart failure due to a reversible condition
- •Hypertrophic obstructive cardiomyopathy (HOCM)
- •Left ventricular assist device (LVAD), intra-aortic balloon pump (IABP) or intravenous inotropes are required or the patient has end stage heart failure despite maintenance on best medical therapy
- •Active infection, sepsis, endocarditis, myocarditis or pericarditis
- •Myocardial infarction, stroke, transient ischemic attack, cardiac or other major surgery, or implantable cardioverter defibrillator (ICD) or pacemaker implantation in the 3 months prior to entry
- •Positive pregnancy test for pre-menopausal female
- •Less than 18 years or > or = to 75 years old
- •Hemoglobin level less than 10 gm/dL or creatinine >2.5 mg/dL
- •Uncontrolled medical conditions that increase surgical risk
- •Co-morbid condition that in the investigator's opinion reduces life expectancy to less than 2 years
- •Surgical or Anatomical Considerations
- •Heart measurement too large or small for Implant sizes
- •Restrictive cardiomyopathy
- •Not a candidate for sternotomy or standard thoracotomy surgical approaches
- •Expected to have adhesions from previous surgical procedures
- •History of constrictive pericarditis
- •Previously placed coronary artery bypass grafts (CABG) or anticipated need for coronary artery bypass grafting
- •Not a candidate for cardiopulmonary bypass
- •Anatomical mitral valve regurgitation of 2+ or greater at the time of enrollment
- •Pulmonary function testing with the following results: Forced expiratory volume (FEV1) <1L or if FEV1 is between 1 and 3L, forced expiratory volume divided by forced vital capacity (FEV1/FVC) <60%
- •Cardiac or thoracic condition that might require operative correction. Cardiac transplantation is not included in this exclusion criterion.
- •Other elective surgical procedure at the time of the index hospitalization or within 30 days, whichever is longer
- •Any other medical condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure
- •Currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study
- •Unwilling/unable to comply with follow-up
- •Unwilling/unable to give signed informed consent
研究组 & 干预措施
Treatment
HeartNet and Optimal Medical/Device Therapy (e.g., medications and cardiac resynchronisation therapy)
干预措施: HeartNet Ventricular Support System (Device)
Control
Optimal Medical/Device Therapy alone (e.g., medications and/or cardiac resynchronisation therapy) (Note: For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of angiotensin converting enzyme (ACE) inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as cardiac resynchronization therapy (CRT) or cardiac resynchronization therapy-defibrillator (CRT-D) for at least three months prior to study enrollment, when indicated.)
干预措施: Optimal Medical/Device Therapy (Drug)
结局指标
主要结局
Responder Analysis - Peak Oxygen Uptake (Peak VO2)
时间窗: Baseline to 6 months
A participant was considered a "responder" if cardiopulmonary exercise testing demonstrated an improvement in peak VO2 of at least 1.0 ml/kg/min at 6 months as compared to baseline.
Responder Analysis - Six (6) Minute Walk (6MW) Distance
时间窗: Baseline to 6 months
A participant was considered a "responder" if 6MW distance at 6 months was at least 45 meters more than at baseline.
Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score
时间窗: baseline to 6 months
A participant was considered a "responder" if the MLHF overall score had improved by at least 7 points at 6 months as compared to baseline. THE MLHF questionnaire evaluates the impact of heart failure (HF) on a subject's physical, emotional, social and mental aspects of quality of life. Each of 21 questions about how much HF impacts daily activities is scored from 0-no impact to 5-very much (overall score can range from 0 to 105). Improvement is indicated by a decrease in score.
Number of Participant Deaths
时间窗: 12 months
Total number of participants who died within 12 months of enrollment into the trial.
次要结局
- Responder Analysis - Six (6) Minute Walk (6MW) Distance(baseline to 12 Months)
- Change in New York Heart Association (NYHA) Functional Class(baseline to 6 months)
- Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(baseline to 6 months)
- Change in Left Ventricular Mass(baseline to 6 months)
- Responder Analysis - Peak Oxygen Uptake (Peak VO2)(baseline to 12 months)
- Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score(baseline to 12 months)
- Heart Failure Hospitalization - Actuarial Analysis(12 months)
- Change in Left Ventricular End Diastolic Volume(baseline to 6 months)
- Change in Left Ventricular End Systolic Volume(baseline to 6 months)
- Change in Ejection Fraction(baseline to 6 months)
- Change in Left Ventricular End Diastolic Diameter(baseline to 6 months)
- Change in Left Ventricular End Systolic Diameter(baseline to 6 months)
- Technical Success (Number of Treatment Arm Participants Successfully Implanted)(1 day)
- Heart Failure Death(12 months)
- Heart Failure Death - Actuarial Analysis(12 months)
- Heart Failure Hospitalization(12 months)
- All-Cause Hospitalization(12 months)
- All-Cause Hospitalization - Actuarial Analysis(12 months)
- Participants Experiencing Serious Adverse Events(12 months)
- Serious Adverse Events - Actuarial Analysis(12 months)
- Days Alive Out of Hospital(12 months)