What this study is
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.
What's being tested
- Controlled Cardiac Reloading through LVAD Speed Adjustment
Intervention · 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
- Official title
- Sequential Left Ventricular Assist Device (LVAD) Unloading and Conditioning to Induce Sustained Cardiac Recovery
- Sponsor
- STAVROS G DRAKOS
- Conditions
- Heart Failure
- Enrolling
- 100 people
- Starts
- 2017-06-23
- Est. completion
- 2028-06-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Utah
Salt Lake City, Utah, United States
- Stavros Drakos, MD · Contact801-585-2340stavros.drakos@hsc.utah.edu
- Stavros Drakos, MD · Principal investigator
Recruiting
Study team
Sponsor
STAVROS G DRAKOS
Study ID IRB_00095106
Principal investigator
Stavros Drakos, MD
University of Utah
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.