Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remission From Stage D Heart Failure (RESTAGE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01774656
Recruitment Status : Unknown
Verified April 2017 by Emma Birks, University of Louisville.
Recruitment status was:  Recruiting
First Posted : January 24, 2013
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Emma Birks, University of Louisville

Tracking Information
First Submitted Date  ICMJE January 22, 2013
First Posted Date  ICMJE January 24, 2013
Last Update Posted Date April 27, 2017
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01774656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • The proportion of evaluable subjects meeting explant criteria and subsequently explanted [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ]
  • The time course of reverse remodeling on a left ventricular assist device [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ]
  • The time course and sustainability of reverse remodeling following LVAD explantation [ Time Frame: 12-18 months ]
  • Predictors of recovery and device removal [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ]
  • Changes in maximal and sub maximal exercise capacity [ Time Frame: 12-18 months ]
  • Changes in renal function and hepatic enzymes [ Time Frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months ]
  • Changes in EF measured at 6000RPM. [ Time Frame: 6 weeks, 4, 6, 9, 12-18 months ]
  • Changes in quality of life, as measured by the EuroQoL (EQ5D) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remission From Stage D Heart Failure
Official Title  ICMJE Remission From Stage D Heart Failure (RESTAGE-HF)
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure NYHA Class III
  • Heart Failure NYHA Class IV
Intervention  ICMJE 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.
Study Arms  ICMJE 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.

Intervention: Drug: Pharmacological Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 22, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774656
Other Study ID Numbers  ICMJE RESTAGE-UL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emma Birks, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Thoratec Corporation
Investigators  ICMJE
Principal Investigator: Emma Birks, MD University of Louisville
PRS Account University of Louisville
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP