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

NCT00382863 | Terminated Phase 2 Results DMC

• 1 other identifier: 200
• Study Type: interventional
• Target: 220
• Locations: 2 countries
• Sites: 35

Brief Summary

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.

Conditions

Heart Failure

Keywords

heart failure; cardiac support; Paracor; HeartNet; PEERLESS-HF

Outcome Measures

Primary Outcomes (4)

• Responder Analysis - Peak Oxygen Uptake (Peak VO2)

  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.

  Baseline to 6 months

• Responder Analysis - Six (6) Minute Walk (6MW) Distance

  A participant was considered a "responder" if 6MW distance at 6 months was at least 45 meters more than at baseline.

  Baseline to 6 months

• Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score

  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.

  baseline to 6 months

• Number of Participant Deaths

  Total number of participants who died within 12 months of enrollment into the trial.

  12 months

Secondary Outcomes (21)

• 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 - Six (6) Minute Walk (6MW) Distance

  baseline to 12 Months

Study Arms (2)

Treatment

EXPERIMENTAL

HeartNet and Optimal Medical/Device Therapy (e.g., medications and cardiac resynchronisation therapy)

Device: HeartNet Ventricular Support System

Control

ACTIVE COMPARATOR

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.)

Drug: Optimal Medical/Device Therapy

Interventions

HeartNet Ventricular Support System DEVICE

The HeartNet Implant is placed on the epicardial surface of the heart surrounding both the left and right ventricles.

Also known as: cardiac support

Treatment

Optimal Medical/Device Therapy DRUG

Optimal Medical/Device Therapy - For the purpose of the PEERLESS-HF study, optimal medical therapy is defined as the use of ACE inhibitors and Beta blockers in the highest tolerable doses for three months prior to study enrollment, and Optimal device therapy is defined as CRT or CRT-D for at least three months prior to study enrollment, when indicated.

Also known as: heart failure medications

Control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Paracor Medical, Inc: lead

Study Sites (35)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

USC Keck School of Medicine

Los Angeles, California, 90033, United States

Location

University of California, San Francisco, Medical Center

San Francisco, California, 94143, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Midwest Heart Foundation

Lombard, Illinois, 60148, United States

Location

St. Vincent Hospital and Health Services

Indianapolis, Indiana, 46260, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

University of Maryland, Division of Cardiology

Baltimore, Maryland, 21201, United States

Location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Wayne State University/ Oakwood Hospital

Detroit, Michigan, 48201, United States

Location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

BryanLGH Heart Improvement Program

Lincoln, Nebraska, 68506, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

The Stern Cardiovascular Center

Germantown, Tennessee, 38138, United States

Location

Tennessee Cardiovascular Research Institute

Nashville, Tennessee, 37205, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Inova Heart & Vascular Institute/ Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Hospital Centre

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (2)

• Abraham WT, Anand I, Aranda JM Jr, Boehmer J, Costanzo MR, DeMarco T, Holcomb R, Ivanhoe R, Kolber M, Rayburn B. Randomized controlled trial of ventricular elastic support therapy in the treatment of symptomatic heart failure: rationale and design. Am Heart J. 2012 Nov;164(5):638-45. doi: 10.1016/j.ahj.2012.07.015. Epub 2012 Oct 2.

  PMID: 23137493 DERIVED

• Keteyian SJ, Brawner CA, Ehrman JK, Ivanhoe R, Boehmer JP, Abraham WT; PEERLESS-HF Trial Investigators. Reproducibility of peak oxygen uptake and other cardiopulmonary exercise parameters: implications for clinical trials and clinical practice. Chest. 2010 Oct;138(4):950-5. doi: 10.1378/chest.09-2624. Epub 2010 Jun 3.

  PMID: 20522572 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

An interim analysis indicated trial futility based on a primary endpoint. Enrollment was suspended in July, 2009. Study was terminated as of April, 2011 due to insufficient resources.

Results Point of Contact

• Title: Michael Kolber, General Manager, VP of Regulatory Affairs
• Organization: Paracor Medical, Inc.

info@paracor.com

408-734-6000

Study Officials

• William T. Abraham, MD

  Chief, Division of Cardiovascular Medicine, The Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2006
• First Posted: October 2, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2012
• Last Updated: July 13, 2012
• Results First Posted: July 13, 2012

Record last verified: 2012-06

Locations

CA (6); US (29)