Remission From Stage D Heart Failure

Last updated: April 25, 2017
Sponsor: University of Louisville
Overall Status: Trial Status Unknown

Phase

4

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

N/A

Clinical Study ID

NCT01774656
RESTAGE-UL
  • Ages 18-59
  • All Genders

Study Summary

The purpose of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function after undergoing a standardized Left Ventricular Assist Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject age between 18 - 59 years, inclusive

  2. Subject indicated for DT or BTT

  3. Subject with severe clinical heart failure resistant to intensive medical therapy andrequiring LVAD implantation

  4. Subject with LVEF < 25% and cardiomegaly at the time of LVAD implantation asdocumented by radionuclide or contrast ventriculography or by echocardiography

  5. Subject with non-ischemic etiology (confirmed by angiography either within 2 years ofimplantation or prior to explantation)

  6. Subject have undergone HM II implantation within prior 4 weeks or planned for a HM IIimplant

  7. Subject has a history of HF < 5 years.

Exclusion

Exclusion Criteria:

  1. Subject has evidence of active acute myocarditis confirmed by histology

  2. Subject has a history of previous CVA resulting in significant fixed motor deficitlimiting ability to perform exercise testing

  3. Subject has been implanted with a mechanical aortic and/or mitral valve(s)

  4. Subject had an aortic valve closure

  5. Subject diagnosed with a hypertrophic obstructive cardiomyopathy or sarcoidosis

  6. Subject with LVEDD below normal confirmed by surface echocardiogram (restrictivecardiomyopathy)

  7. Subject has irreversible multi-organ failure

  8. Pregnant or lactating women or unwilling to utilize two reliable methods of birthcontrol for women of childbearing age

  9. Subject is diagnosed with a psychiatric disease, irreversible cognitive dysfunction orpoor psychosocial issues that is likely to impair compliance with the study protocol

  10. Subject with any condition, other than heart failure, that could limit survival toless than 2 years

  11. Subject has a history of cardiac or other organ transplant

  12. Subject is contraindicated to anticoagulation antiplatelet therapy

  13. Subject requires acute or chronic renal replacement therapy (e.g. chronic dialysis)within 3 months prior to enrollment

  14. Subject participating in any other clinical investigations involving anotherMechanical Circulatory Support (MCS) device or heart failure related drug, orinvestigations which are likely to confound study results or affect study outcome.

Study Design

Total Participants: 40
Study Start date:
January 01, 2013
Estimated Completion Date:
December 31, 2017

Study Description

The encouraging results from the LVAD based recovery series suggest that the significant hemodynamic unloading provided by the Mechanical Circulatory Support (MCS) in conjunction with aggressive pharmacological treatment may induce a profound reverse structural remodeling and in turn result in a curative alternative to a specific patient population with severe heart failure. The active identification and characterization of the patients with a high potential for full cardiac function recovery is of paramount importance. The development of a standard and simplified recovery protocol would ultimately lead to a larger bridge to recovery patient population. The primary objective of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function (remission from heart failure) after undergoing a standardized LVAD plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months. The secondary objectives of this study are twofold, first to determine the durability of sustained remission from HF following LVAD explantation at 12 months and up to 3 years and second to determine the predictors of recovery.

Connect with a study center

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Montefiore Medical Center

    New York, New York 10467
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

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