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HeartMate II plus Pharmacological Treat for Heart Failure (RESTAGE-HF Trial)

Phase 4
Waitlist Available
Led By Emma Birks, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3, 4, 5, 6, 9, 12-18 months
Awards & highlights

RESTAGE-HF Trial 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.

Eligible Conditions
  • Heart Failure

RESTAGE-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3, 4, 5, 6, 9, 12-18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3, 4, 5, 6, 9, 12-18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation
Secondary outcome measures
Changes in EF measured at 6000RPM.
Changes in maximal and sub maximal exercise capacity
Changes in quality of life, as measured by the EuroQoL (EQ5D)
+5 more

RESTAGE-HF Trial Design

1Treatment groups
Experimental Treatment
Group I: HeartMate II plus Pharmacological TreatExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,944 Total Patients Enrolled
3 Trials studying Heart Failure
33 Patients Enrolled for Heart Failure
Thoratec CorporationIndustry Sponsor
22 Previous Clinical Trials
3,209 Total Patients Enrolled
15 Trials studying Heart Failure
2,430 Patients Enrolled for Heart Failure
Emma Birks, MDPrincipal InvestigatorUniversity of Louisville

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Remission From Stage D Heart Failure
Emma Birks 2013. "Remission From Stage D Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01774656.
All > Heart Failure With Preserved Ejection Fraction
~3 spots leftby Apr 2025
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