Remission From Stage D Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 59
Updated:4/21/2016
Start Date:January 2013
End Date:December 2017
Contact:Chris Cunningham, PhD
Email:chris.cunningham@louisville.edu

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Remission From Stage D Heart Failure (RESTAGE-HF)

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.

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.

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 and
requiring LVAD implantation

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

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

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

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

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 deficit
limiting 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 (restrictive
cardiomyopathy)

7. Subject has irreversible multi-organ failure

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

9. Subject is diagnosed with a psychiatric disease, irreversible cognitive dysfunction
or poor 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 to
less 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 another
Mechanical Circulatory Support (MCS) device or heart failure related drug, or
investigations which are likely to confound study results or affect study outcome.
We found this trial at
6
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: J E Rame, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Maria Mountis, D.O.
Phone: 216-445-6552
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Craig Selzman, MD
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Emma Birks, MD, PhD
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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New York, New York 10467
Principal Investigator: Snehal Patel, MD
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New York, NY
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Brian D Lowes, MD, PhD
Phone: 402-559-5127
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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