Recruiting

Cardiac Recovery

Sponsor:

STAVROS G DRAKOS

Code:

NCT03238690

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Controlled Cardiac Reloading through LVAD Speed Adjustment

Study Details

Brief summary:

The purpose of this study is to investigate the potential recovery of heart function in end-stage heart failure patients supported with a Left Ventricular Assist Device (LVAD) through applying a myocardial conditioning protocol. During myocardial conditioning, LVAD speed is reduced gradually in order to increase the work load of the heart. Multiple previous studies have shown that interventions like this may improve heart function and give patients the opportunity for a better quality of life.

Conditions

Heart Failure

Study ID

NCT03238690

Start date

Jun 23, 2017

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed with heart failure undergoing LVAD implantation as a bridge to transplant
  • Enrolled in the Effects of Mechanical Unloading on Myocardial Function and Structure study (IRB 30622)

Exclusion Criteria:

  • Neither the subject nor the subject's representative is willing to provide written consent for participation
  • Subjects with adverse events leading to hospitalization during the optimum unloading phase are excluded from participation in the controlled reloading phase

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Controlled Cardiac Reloading

Heart failure patients with recent LVAD implantation after an optimum unloading phase, will undergo controlled cardiac reloading through LVAD speed adjustment reductions in a controlled reloading phase

Interventions

Controlled Cardiac Reloading through LVAD Speed Adjustment

LVAD speed is reduced at a fixed rate according to the particular LVAD device model implanted. LVAD speed reduction adjustments will be performed at visits occurring every 2 - 3 weeks, up to a total of 8 visits. Reduction of LVAD speed will continue until the soonest of: minimum operating setting as recommended in the LVAD Operator's manual is reached; the minimum setting tolerated by the subject is reached; the subject completes 8 visits; or until the subject receives a heart transplant.

Primary outcome measure

  • Change in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant ]

Central Contacts and Locations

Central contacts

John Kirk

801-585-2944john.kirk@hsc.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Stavros Drakos, MD

801-585-2340stavros.drakos@hsc.utah.edu

Principal Investigator:

Stavros Drakos, MD

More Information

Sponsor

STAVROS G DRAKOS

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • LVAD
  • Cardiac Recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by STAVROS G DRAKOS on 2026-08-13.