Improving heart function in patients with LVAD support
Sequential Left Ventricular Assist Device (LVAD) Unloading and Conditioning to Induce Sustained Cardiac Recovery
This study is testing if gradually reducing the speed of a heart pump can help improve heart function and quality of life for people with severe heart failure who are using a Left Ventricular Assist Device (LVAD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT03238690 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential recovery of heart function in patients with end-stage heart failure who are supported by a Left Ventricular Assist Device (LVAD). It employs a myocardial conditioning protocol that gradually reduces LVAD speed to increase the workload on the heart, potentially improving its function. The study aims to explore how this approach can reverse chronic left ventricular remodeling and enhance the quality of life for these patients. Previous studies suggest that such interventions may lead to significant improvements in heart function.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with heart failure who are undergoing LVAD implantation as a bridge to transplant.
Not a fit: Patients who are unwilling to provide consent or have experienced adverse events leading to hospitalization during the unloading phase may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart function and quality of life for patients with end-stage heart failure.
How similar studies have performed: Previous studies have shown promise with similar approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Salt Lake City, Utah
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Stavros Drakos, MD — University of Utah
- Study coordinator: John Kirk
- Email: john.kirk@hsc.utah.edu
- Phone: 801-585-2944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.