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Remission From Stage D Heart Failure (RESTAGE-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Louisville
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Emma Birks, University of Louisville
ClinicalTrials.gov Identifier:
NCT01774656
First received: January 22, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
NYHA Class IIIB/IV Patients Eligible for HeartMate II Implant Either as BTT or DT
Device: HeartMate II
Drug: Pharmacological Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Remission From Stage D Heart Failure (RESTAGE-HF)

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of evaluable subjects meeting explant criteria and subsequently explanted [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ] [ Designated as safety issue: No ]
  • The time course of reverse remodeling on a left ventricular assist device [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ] [ Designated as safety issue: No ]
  • The time course and sustainability of reverse remodeling following LVAD explantation [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
  • Predictors of recovery and device removal [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ] [ Designated as safety issue: No ]
  • Changes in maximal and sub maximal exercise capacity [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
  • Changes in renal function and hepatic enzymes [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ] [ Designated as safety issue: No ]
  • Changes in EF measured at 6000RPM. [ Time Frame: 6 weeks, 4, 6, 9, 12-18 months ] [ Designated as safety issue: No ]
  • Changes in quality of life, as measured by the EuroQoL (EQ5D) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HeartMate II plus Pharmacological Treat

The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.

The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ recovery and titrated (against symptoms, potassium, and renal function) to the following maximum doses: lisinopril 40 mg daily; carvedilol 25 mg 3 times daily; spironolactone 25 mg daily; digoxin 125g daily, and losartan 150 mg daily.

Device: HeartMate II
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
Drug: Pharmacological Treatment
The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ recovery and titrated (against symptoms, potassium, and renal function) to the following maximum doses: lisinopril 40 mg daily; carvedilol 25 mg 3 times daily; spironolactone 25 mg daily; digoxin 125g daily, and losartan 150 mg daily.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774656

Contacts
Contact: Chris Cunningham, PhD chris.cunningham@louisville.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Terry Blanton, BSN, RN       mtblan02@louisville.edu   
Principal Investigator: Emma Birks, MD, PhD         
United States, New York
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Auris Brown       aubrowne@montefiore.org   
Contact: Johanna Oviedo    718-920-8780    joviedo@montefiore.org   
Principal Investigator: Snehal Patel, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Barb Gus, RN BSN CCRC    216-445-6552    GUSB@ccf.org   
Principal Investigator: Maria Mountis, D.O.         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Judith Marble       Judith.Marble@uphs.upenn.edu   
Principal Investigator: J E Rame, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Erin Davis, RN       erin.davis@hsc.utah.edu   
Principal Investigator: Craig Selzman, MD         
Sponsors and Collaborators
University of Louisville
Thoratec Corporation
  More Information

No publications provided

Responsible Party: Emma Birks, M.D., Ph.D., University of Louisville
ClinicalTrials.gov Identifier: NCT01774656     History of Changes
Other Study ID Numbers: RESTAGE-UL
Study First Received: January 22, 2013
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
HeartMate II, heart-assist device, left-ventricle assist device, reverse remodeling, recovery, pump explant

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014