LVAD Conditioning for Cardiac Recovery

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
STAVROS G DRAKOS
Study ID
NCT03238690
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Controlled Cardiac Reloading through LVAD Speed Adjustment — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 23, 2017
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84112
Stavros Drakos, MD
[email protected]
801-585-2340
Stavros Drakos, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
University of Utah· Salt Lake City, UT

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