NCT01774656

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

4.9 years

First QC Date

January 22, 2013

Last Update Submit

April 25, 2017

Conditions

Heart Failure NYHA Class IIIHeart Failure NYHA Class IV

Keywords

heart-assist device

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation

    12 months

Secondary Outcomes (8)

  • The proportion of evaluable subjects meeting explant criteria and subsequently explanted

    6 weeks, 3, 4, 5, 6, 9, 12-18 months

  • The time course of reverse remodeling on a left ventricular assist device

    6 weeks, 3, 4, 5, 6, 9, 12-18 months

  • The time course and sustainability of reverse remodeling following LVAD explantation

    12-18 months

  • Predictors of recovery and device removal

    6 weeks, 3, 4, 5, 6, 9, 12-18 months

  • Changes in maximal and sub maximal exercise capacity

    12-18 months

  • +3 more secondary outcomes

Study Arms (1)

HeartMate II plus Pharmacological Treat

EXPERIMENTAL

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.

Drug: Pharmacological Treatment

Interventions

Pharmacological TreatmentDRUG

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.

HeartMate II plus Pharmacological Treat

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject age between 18 - 59 years, inclusive
  • Subject indicated for DT or BTT
  • Subject with severe clinical heart failure resistant to intensive medical therapy and requiring LVAD implantation
  • Subject with LVEF \< 25% and cardiomegaly at the time of LVAD implantation as documented by radionuclide or contrast ventriculography or by echocardiography
  • Subject with non-ischemic etiology (confirmed by angiography either within 2 years of implantation or prior to explantation)
  • Subject have undergone HM II implantation within prior 4 weeks or planned for a HM II implant
  • Subject has a history of HF \< 5 years.

You may not qualify if:

  • Subject has evidence of active acute myocarditis confirmed by histology
  • Subject has a history of previous CVA resulting in significant fixed motor deficit limiting ability to perform exercise testing
  • Subject has been implanted with a mechanical aortic and/or mitral valve(s)
  • Subject had an aortic valve closure
  • Subject diagnosed with a hypertrophic obstructive cardiomyopathy or sarcoidosis
  • Subject with LVEDD below normal confirmed by surface echocardiogram (restrictive cardiomyopathy)
  • Subject has irreversible multi-organ failure
  • Pregnant or lactating women or unwilling to utilize two reliable methods of birth control for women of childbearing age
  • Subject is diagnosed with a psychiatric disease, irreversible cognitive dysfunction or poor psychosocial issues that is likely to impair compliance with the study protocol
  • Subject with any condition, other than heart failure, that could limit survival to less than 2 years
  • Subject has a history of cardiac or other organ transplant
  • Subject is contraindicated to anticoagulation antiplatelet therapy
  • Subject requires acute or chronic renal replacement therapy (e.g. chronic dialysis) within 3 months prior to enrollment
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10467, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (1)

  • Birks EJ, Drakos SG, Patel SR, Lowes BD, Selzman CH, Starling RC, Trivedi J, Slaughter MS, Alturi P, Goldstein D, Maybaum S, Um JY, Margulies KB, Stehlik J, Cunningham C, Farrar DJ, Rame JE. Prospective Multicenter Study of Myocardial Recovery Using Left Ventricular Assist Devices (RESTAGE-HF [Remission from Stage D Heart Failure]): Medium-Term and Primary End Point Results. Circulation. 2020 Nov 24;142(21):2016-2028. doi: 10.1161/CIRCULATIONAHA.120.046415. Epub 2020 Oct 26.

    PMID: 33100036DERIVED

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Emma Birks, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Cunningham, PhD

CONTACT

chris.cunningham@louisville.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

US(6)