Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure (PEERLESS-HF) Trial

Stopped early · Phase 2/Phase 3

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00382863

Run by

Paracor Medical, Inc

People needed

220

Starts

2006-10-01

Expected to finish

2012-05-01

Last updated by the study team

2012-07-13

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Myxoma
• 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
• Other

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• USC Keck School of Medicine — Los Angeles, California, United States
• University of California, San Francisco, Medical Center — San Francisco, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Christiana Care Health System — Newark, Delaware, United States
• University of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Midwest Heart Foundation — Lombard, Illinois, United States
• St. Vincent Hospital and Health Services — Indianapolis, Indiana, United States
• Genesis Medical Center — Davenport, Iowa, United States
• University of Maryland, Division of Cardiology — Baltimore, Maryland, United States
• Caritas St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Wayne State University/ Oakwood Hospital — Detroit, Michigan, United States
• Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
• St. Paul Heart Clinic — Saint Paul, Minnesota, United States
• Mid America Heart Institute — Kansas City, Missouri, United States
• BryanLGH Heart Improvement Program — Lincoln, Nebraska, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.