Heart Failure Clinical Trial
Official title:
Sequential Left Ventricular Assist Device (LVAD) Unloading and Conditioning to Induce Sustained Cardiac Recovery
Verified date | June 2023 |
Source | University of Utah |
Contact | John Kirk |
Phone | 801-585-2944 |
john.kirk[@]hsc.utah.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - Neither the subject nor the subject's representative understands spoken English - Subjects with adverse events leading to hospitalization during the optimum unloading phase are excluded from participation in the controlled reloading phase |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
STAVROS G DRAKOS | American Heart Association |
United States,
Frazier OH, Baldwin AC, Demirozu ZT, Segura AM, Hernandez R, Taegtmeyer H, Mallidi H, Cohn WE. Ventricular reconditioning and pump explantation in patients supported by continuous-flow left ventricular assist devices. J Heart Lung Transplant. 2015 Jun;34(6):766-72. doi: 10.1016/j.healun.2014.09.015. Epub 2014 Sep 28. — View Citation
George RS, Sabharwal NK, Webb C, Yacoub MH, Bowles CT, Hedger M, Khaghani A, Birks EJ. Echocardiographic assessment of flow across continuous-flow ventricular assist devices at low speeds. J Heart Lung Transplant. 2010 Nov;29(11):1245-52. doi: 10.1016/j.healun.2010.05.032. Epub 2010 Aug 5. — View Citation
Healy AH, Koliopoulou A, Drakos SG, McKellar SH, Stehlik J, Selzman CH. Patient-controlled conditioning for left ventricular assist device-induced myocardial recovery. Ann Thorac Surg. 2015 May;99(5):1794-6. doi: 10.1016/j.athoracsur.2014.07.058. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant | |
Secondary | 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. | Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant | |
Secondary | 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. | Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant | |
Secondary | 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. | Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant | |
Secondary | 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. | Baseline (prior to LVAD implantation) and 12 months post-LVAD implantation, or at time of LVAD explantation/heart transplant | |
Secondary | Change in heart tissue Glucose 1-phosphate levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Glucose 1-phosphate levels. The average change in Glucose 1-phosphate from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Glucose 6-phosphate levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Glucose 6-phosphate levels. The average change in Glucose 6-phosphate from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Pyruvate levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Pyruvate levels. The average change in Pyruvate from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Lactic Acid levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Lactic Acid levels. The average change in Lactic Acid from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Acetyl Coenzyme A levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for Acetyl Coenzyme A levels. The average change in Acetyl Coenzyme A from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Glucose Transporter 1 (GLUT1) levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT1 levels. The average change in GLUT1 from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Glucose Transporter 1 (GLUT1) messenger ribonucleic acid (mRNA) levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT1 mRNA levels. The average change in GLUT1 mRNA from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Glucose Transporter 4 (GLUT4) levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT4 levels. The average change in GLUT4 from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Glucose Transporter 4 (GLUT4) messenger ribonucleic acid (mRNA) levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for GLUT4 mRNA levels. The average change in GLUT4 mRNA from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Mitochondrial Pyruvate Carrier 1 (MPC1) levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for MPC1 levels. The average change in MPC1 from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Mitochondrial Pyruvate Carrier 2 (MPC2) levels | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for MPC2 levels. The average change in MPC2 from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) | |
Secondary | Change in heart tissue Mitochondrial Density | Heart tissue samples will be collected at LVAD implantation when the tissue from the core becomes available and then at explant when the whole heart becomes available, and will be analyzed for mitochondrial density by electron microscopy. The average change in mitochondrial density from baseline to transplant in the study participant arm will be compared to results from an historical control group. | Baseline (LVAD implantation) and at time of LVAD explantation/heart transplantation (up to 12 months) |
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