This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center. Participation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study. Participants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.
Percutaneous endovascular mechanical circulatory support (MCS) devices have been increasingly utilized in patients on the waitlist for heart transplantation in the new heart allocation system. However, the number of patients recovering from heart failure and delisted from cardiac transplantation has declined in the new heart allocation system. While significant research has been performed on myocardial recovery with durable left ventricular assist device (LVAD) support, natural course and mechanistic basis of reverse remodeling on percutaneous endovascular MCS remains unknown. The primary objective of this prospective, observational, single-center study is to evaluate whether mechanical circulatory support with Impella 5.5 LVAD in decompensated patients on the waitlist for heart transplantation results in left ventricular reverse remodeling and improvement in end-organ function within 14 days of initiating support. Phenotypic data including clinical information, echocardiography, and hemodynamics will be serially obtained in participants before and after Impella 5.5 LVAD placement. Paired serum samples (pre- and post- Impella support) will be obtained for proteomic analysis. Cardiac tissue samples will be collected at the time of cardiac transplantation for histopathological analysis as well as RNA-sequencing. Candidate genes and proteins of reverse remodeling will be validated using quantitative polymerase chain reaction (qPCR) and Western Blotting. This study will definitively establish the natural course of reverse remodeling in patients with chronically failing ventricles on Impella 5.5 support and determine molecular signals and novel biomarkers of myocardial recovery in this growing population. Data obtained from this study will help determine which patients should pursue recovery pathway as opposed to transplant.
Study Type
OBSERVATIONAL
Enrollment
50
Columbia University
New York, New York, United States
RECRUITINGChange in Left Ventricular Ejection Fraction (LVEF)
A change in echocardiographic index will be evaluated by measuring a change in LVEF before and after Impella support at minimal pump setting.
Time frame: Baseline and approximately Day 40
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
A change in echocardiographic index will be evaluated by measuring a change in LVEDD before and after Impella support at minimal pump setting.
Time frame: Baseline and approximately Day 40
Change in Cardiac Index
A change in hemodynamics will be evaluated by measuring a change in cardiac index before and after Impella support at minimal pump speed setting (P2).
Time frame: Baseline and approximately Day 40
Change in Pulmonary Capillary Wedge Pressure
A change in hemodynamics will be evaluated by measuring a change in Pulmonary Capillary Wedge Pressure before and after Impella support at minimal pump speed setting (P2).
Time frame: Baseline and approximately Day 40
Transplant Waitlist Outcome
The transplant waitlist outcome will be evaluated and the number of participants who die, are delisted due to worsening clinical condition, are transplanted, or are delisted for recovery will be reported.
Time frame: 14 months
Number of Participants Escalated
Number of participants escalated to extracorporeal membrane oxygenation (ECMO) or other temporary/durable mechanical circulatory support (MCS).
Time frame: 14 months
Waitlist time on Impella Support
Waitlist time on Impella support measured in days from the date of Impella insertion to heart transplantation or other waitlist end-point.
Time frame: 14 months
Change in aminoterminal pro B-type natriuretic peptide (NT-proBNP)
Change in NT-proBNP levels collected from blood samples and measured in pg/mL.
Time frame: Baseline and approximately Day 40
Change in Blood Urea Nitrogen (BUN)
Change in BUN levels collected from blood samples and measured in mg/dL.
Time frame: Baseline and approximately Day 40
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR collected from blood samples and measured in mL/min/1.73m\^2.
Time frame: Baseline and approximately Day 40
Change in Cystatin C
Change in Cystatin C collected from blood samples and measured in mg/L.
Time frame: Baseline and approximately Day 40
Change in Total Bilirubin
Change in Total Bilirubin collected from blood samples and measured in mg/dL.
Time frame: Baseline and approximately Day 40
Change in Aspartate Aminotransferase (AST)
Change in AST collected from blood samples and measured in U/L.
Time frame: Baseline and approximately Day 40
Change in Alanine Aminotransferase (ALT)
Change in ALT collected from blood samples and measured in U/L.
Time frame: Baseline and approximately Day 40
Change in International Normalized Ratio (INR)
Change in INR collected from blood samples. INR is a ratio and has no units of measure.
Time frame: Baseline and approximately Day 40
Change in Hemoglobin
Change in hemoglobin levels collected from blood samples and measured in g/L.
Time frame: Baseline and approximately Day 40
Change in Platelet Count
Change in platelet count collected from blood samples and measured in pl/μL.
Time frame: Baseline and approximately Day 40
Change in Lactate dehydrogenase (LDH)
Change in LDH collected from blood samples and measured in U/L.
Time frame: Baseline and approximately Day 40
Change in Plasma Free Hemoglobin
Change in plasma free hemoglobin collected from blood samples and measured in mg/dL.
Time frame: Baseline and approximately Day 40
Change in Prealbumin
Change in prealbumin collected from blood samples and measured in mg/dL.
Time frame: Baseline and approximately Day 40
Change in Albumin
Change in albumin collected from blood samples and measured in mg/dL.
Time frame: Baseline and approximately Day 40
Change in C-Reactive Protein (CRP)
Change in CRP collected from blood samples and measured in mg/L.
Time frame: Baseline and approximately Day 40
Change in Erythrocyte Sedimentation Rate (ESR)
Change in ESR collected from blood samples and measured in mm/hr.
Time frame: Baseline and approximately Day 40
Change in Procalcitonin
Change in procalcitonin collected from blood samples and measured in ng/mL.
Time frame: Baseline and approximately Day 40
Change in HLA Allosensitization Profile
Change in the HLA allosensitization profile. Allosensitization is the presence of circulating antibodies against human leukocyte antigens and nonhuman leukocyte antigens.
Time frame: Baseline and approximately Day 40
Change in Vasoactive-Inotropic Score (VIS)
Vasoactive-Inotropic Score (VIS) is calculated with the following formula: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min). Scores range from 0 to no upper limit, with a higher score indicating a worse outcome.
Time frame: Baseline and approximately Day 40
Six Minute Walk Test (6MWT)
The 6MWT is a measure of performance that assesses the distance walked in six minutes measured in meters. the 6MWT will be conducted in the Cardiac Care Unit (CCU) on device support.
Time frame: 14 months
Change in Upper Extremity Hand Strength
Change in upper extremity strength measured by Handgrip dynamometry in kilograms.
Time frame: 14 months
Units of Blood Used During Heart Transplant
Units of red blood cells, cryoprecipitate, fresh frozen plasma, and platelets used during transplant.
Time frame: Day of Transplant (Approximately Day 40)
Primary Graft Failure
The number of participants with primary graft failure after heart transplantation. Graft failure defined as left ventricular ejection fraction of \<40%.
Time frame: 14 months
Early Transplant Rejection
The number of participants with early transplant rejection. Early transplant rejected defined as an episode of rejection within the first 3 months of transplant.
Time frame: 14 months
AlloMap Score
AlloMap score after heart transplantation. AlloMap measures the risk of acute cellular rejection. Scores range from 0 - 40 with higher score indicating a worse outcome.
Time frame: After Transplant, approximately Day 40
Allosure Score
Allosure score after heart transplantation. Allosure measures the risk of rejection in heart transplant recipients. Scores range from a lower limit of \< 0.04 and above with a higher score indicating a worse outcome.
Time frame: After Transplant, approximately Day 40
Post-Transplant Length of Stay
Post-transplant length of hospital stay measured in days and assessed for up to 14 months.
Time frame: Up to 14 months (approximately 420 days)
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