LVAD Conditioning for Cardiac Recovery
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSTAVROS G DRAKOS
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Controlled Cardiac Reloading through LVAD Speed Adjustment
DeviceLVAD 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Controlled Cardiac ReloadingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Left Ventricular Ejection Fraction (LVEF)
LVEF is measured by echocardiography. The average change in LVEF from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Time frame
Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplantSecondary outcomes
1
Change in Left Ventricular End Diastolic Diameter (LVEDD)
LVEDD is measured by echocardiography. The average change in LVEDD from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Time frame
Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant2
Change in Left Ventricular End Systolic Diameter (LVESD)
LVESD is measured by echocardiography. The average change in LVESD from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Time frame
Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant3
Change in Left Ventricular End Diastolic Volume (LVEDV)
LVEDV is measured by echocardiography. The average change in LVEDV from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Time frame
Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant4
Change in Left Ventricular End Systolic Volume (LVESV)
LVESV is measured by echocardiography. The average change in LVESV from baseline to 12 months or transplant in the study participant arm will be compared to results from an historical control group.
Time frame
Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
STAVROS G DRAKOS
Lead sponsor
University of Utah
Sponsor institution
Source ClinicalTrials.gov