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Heart FailurePhase 2/3PEERLESS-HFNCT00382863

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

A Phase 2/3 study testing HeartNet Ventricular Support System and Optimal Medical/Device Therapy in people with Heart Failure, run by Paracor Medical, Inc at 35 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Heart Failure
What is being tested?
HeartNet Ventricular Support System and Optimal Medical/Device Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
35 sitesin 2 countries
Study dates
Oct 2006to May 2012
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • 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

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

United States29 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • University of Maryland, Division of Cardiology

    Baltimore, Maryland, 21201

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Genesis Medical Center

    Davenport, Iowa, 52803

  • Wayne State University/ Oakwood Hospital

    Detroit, Michigan, 48201

  • Inova Heart & Vascular Institute/ Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of Florida

    Gainesville, Florida, 32610

  • The Stern Cardiovascular Center

    Germantown, Tennessee, 38138

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • St. Vincent Hospital and Health Services

    Indianapolis, Indiana, 46260

  • Mid America Heart Institute

    Kansas City, Missouri, 64111

  • BryanLGH Heart Improvement Program

    Lincoln, Nebraska, 68506

  • Midwest Heart Foundation

    Lombard, Illinois, 60148

  • USC Keck School of Medicine

    Los Angeles, California, 90033

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Tennessee Cardiovascular Research Institute

    Nashville, Tennessee, 37205

  • Christiana Care Health System

    Newark, Delaware, 19718

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma, 73120

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • St. Paul Heart Clinic

    Saint Paul, Minnesota, 55102

  • University of California, San Francisco, Medical Center

    San Francisco, California, 94143

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Canada6 sites

  • University of Calgary

    Calgary, Alberta, T2N 4N1

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • McGill University Hospital Centre

    Montreal, Quebec, H3A 1A1

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

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.

Read the detailed description

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.

Paracor Medical intends to submit data obtained in this clinical trial to support a Pre-Market Approval Application to the United States Food and Drug Administration.

Conditions
Heart Failure
Being tested
HeartNet Ventricular Support System, Optimal Medical/Device Therapy
Keywords
heart failure, cardiac support, Paracor, HeartNet, PEERLESS-HF
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeartNet Ventricular Support SystemDevice

    Also called cardiac support

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

  • Optimal Medical/Device TherapyDrug

    Also called heart failure medications

    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.

Study groups in NCT00382863
Study groupRoleWhat they receive
TreatmentExperimentalHeartNet and Optimal Medical/Device Therapy (e.g., medications and cardiac resynchronisation therapy)
Receives: Device: HeartNet Ventricular Support System
ControlActive comparatorOptimal 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.)
Receives: Drug: Optimal Medical/Device Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 6 months

  2. 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.

    Measured: Baseline to 6 months

  3. 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.

    Measured: baseline to 6 months

  4. Number of Participant Deaths

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

    Measured: 12 months

Secondary outcomes (21)

  1. Change in New York Heart Association (NYHA) Functional Class

    Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remained the same as baseline. "Improved" means the participant's functional class improved (became lower in number) by at least one class. "Worsened" means the participant's functional class deteriorated (became higher in number) by at least one class.

    Measured: baseline to 6 months

  2. Change in Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    The KCCQ is a 23-item questionnaire that quantifies physical function, symptoms, social function, self-efficacy/knowledge and quality of life. Scores range from 0 to 100, where higher scores reflect better health status. For this outcome measure, the difference between each participant's baseline and 6-month KCCQ scores was calculated. The mean change for each treatment arm is presented.

    Measured: baseline to 6 months

  3. Change in Left Ventricular Mass

    The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular mass was calculated. The median change for each treatment arm is presented. A decrease in mass is associated with an improvement in the participant's structural heart failure.

    Measured: baseline to 6 months

  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 12 months as compared to baseline.

    Measured: baseline to 12 months

  5. Responder Analysis - Six (6) Minute Walk (6MW) Distance

    A participant was considered a "responder" if 6MW distance at 12 months was at least 45 meters more than at baseline.

    Measured: baseline to 12 Months

  6. 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 12 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.

    Measured: baseline to 12 months

  7. Heart Failure Hospitalization - Actuarial Analysis

    Kaplan-Meier actuarial analysis of heart failure hospitalization (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment

    Measured: 12 months

  8. Change in Left Ventricular End Diastolic Volume

    The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume is associated with an improvement in the participant's structural heart failure.

    Measured: baseline to 6 months

  9. Change in Left Ventricular End Systolic Volume

    The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic volume was calculated. The median change for each treatment arm is presented. A decrease in volume indicates an improvement in the participant's structural heart failure.

    Measured: baseline to 6 months

  10. Change in Ejection Fraction

    The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular ejection fraction was calculated. The median change for each treatment arm is presented.

    Measured: baseline to 6 months

  11. Change in Left Ventricular End Diastolic Diameter

    The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end diastolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.

    Measured: baseline to 6 months

  12. Change in Left Ventricular End Systolic Diameter

    The difference between each participant's baseline and 6-month echocardiographic measure of left ventricular end systolic diameter was calculated. The median change for each treatment arm is presented. A decrease in diameter indicates an improvement in the participant's structural heart failure.

    Measured: baseline to 6 months

  13. Technical Success (Number of Treatment Arm Participants Successfully Implanted)

    "Technical success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position. Participants who did not undergo an implant procedure were excluded from this analysis.

    Measured: 1 day

  14. Heart Failure Death

    Number of participants who died within 12 months of enrolling in the study and whose cause of death was classified, by an independent Clinical Events Committee, as heart failure

    Measured: 12 months

  15. Heart Failure Death - Actuarial Analysis

    Kaplan-Meier actuarial time-to-event analysis of deaths classified, by an independent Clinical Events Committee, as due to heart failure

    Measured: 12 months

  16. Heart Failure Hospitalization

    Number of participants who experienced a heart failure hospitaliz (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment.

    Measured: 12 months

  17. All-Cause Hospitalization

    Number of participants who experienced a hospitalization (for any cause) within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.

    Measured: 12 months

  18. All-Cause Hospitalization - Actuarial Analysis

    Kaplan-Meier actuarial time-to-first-event analysis of all-cause hospitalizations

    Measured: 12 months

  19. Participants Experiencing Serious Adverse Events

    Number of participants who experienced a serious adverse event (as classified by an independent Clinical Events Committee) within the first 12 months after enrollment

    Measured: 12 months

  20. Serious Adverse Events - Actuarial Analysis

    Kaplan-Meier actuarial time-to-first-event analysis of serious adverse events

    Measured: 12 months

  21. Days Alive Out of Hospital

    Median number of days participants were not hospitalized within the first 12 months after enrollment. Within the Treatment Arm, hospitalization for the implant procedure was not included in this analysis.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionMay 2011
  4. Study completionMay 2012

Why it stopped: Resources unavailable to continue study follow-up.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00382863
Sponsor's protocol ID
200
Acronym
PEERLESS-HF
Status last verified
Jun 2012
First submitted
28 Sep 2006
Last updated
13 Jul 2012
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23137493

  • 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.

    PubMed 20522572

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HeartNet Ventricular Support System and Optimal Medical/Device Therapy in people with Heart Failure, run by Paracor Medical, Inc at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder Analysis - Peak Oxygen Uptake (Peak VO2) (time frame: Baseline to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00382863, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.

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