LVAD Conditioning for Heart Failure
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment LVAD Conditioning for Heart Failure?
Is LVAD Conditioning generally safe for humans?
How is LVAD Conditioning treatment different from other heart failure treatments?
LVAD Conditioning is unique because it involves using a mechanical device to support the heart's function in patients with severe heart failure, providing an alternative to heart transplantation or as a bridge to it. Unlike medications, this treatment physically assists the heart in pumping blood, which can be crucial for patients with advanced heart failure.511121314
Research Team
Stavros Drakos, MD
Principal Investigator
University of Utah
Eligibility Criteria
This trial is for heart failure patients who are getting an LVAD implant as a temporary step before a transplant. They must be part of another study (IRB 30622) and able to give consent. People who don't understand English or have been hospitalized due to complications during earlier treatment phases cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Optimum Unloading Phase
Heart failure patients undergo an optimum unloading phase with LVAD support to stabilize their condition before controlled reloading
Controlled Cardiac Reloading
Participants undergo controlled cardiac reloading through LVAD speed adjustment reductions to promote myocardial recovery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including heart tissue analysis and echocardiography
Treatment Details
Interventions
- LVAD Conditioning
LVAD Conditioning is already approved in European Union, United States, Canada, Japan for the following indications:
- Advanced heart failure
- Bridge to transplant
- Destination therapy
- Advanced heart failure
- Bridge to transplant
- Destination therapy
- Advanced heart failure
- Bridge to transplant
- Destination therapy
- Advanced heart failure
- Bridge to transplant
- Destination therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
STAVROS G DRAKOS
Lead Sponsor
American Heart Association
Collaborator