Heart Failure Clinical Trial
Official title:
Prospective, Randomized-controlled, Non-blinded, Multi-center, Pilot Trial to Compare Standard-of-care LVAD Unloading Plus Heart Failure Medications Reverse-modeling Management Versus Hemodynamics-guided LVAD Unloading With the Use of the Wireless Monitoring System CardioMEMS Plus Heart Failure Medications Reverse-remodeling Management
Verified date | March 2024 |
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 |
This study is a prospective, randomized-controlled, non-blinded, multi-center, pilot trial to compare standard-of-care left ventricular assist device (LVAD) unloading plus heart failure (HF) medications reverse-remodeling management versus hemodynamics-guided LVAD unloading with use of the wireless monitoring system CardioMEMS plus HF medications reverse-remodeling management.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | September 1, 2026 |
Est. primary completion date | September 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Severe clinical HF resistant to intensive medical therapy and requiring LVAD implantation - Left ventricular ejection fraction <=25% and cardiomegaly at time of LVAD implantation - Non-ischemic etiology of HF - Undergone LVAD implantation within prior 4 weeks or planned for LVAD implant - History of HF < 5 years - Body Mass Index <=35 kg/m^2 - Pulmonary artery branch diameter between 7 - 15 mm - Female subjects of childbearing age with negative urine or serum pregnancy test and agreeing to use reliable mechanical or hormonal form of contraception during study Exclusion Criteria: - Evidence of active acute myocarditis confirmed by histology - History of previous cerebrovascular accident resulting in significant fixed motor deficit, limiting ability to perform exercise testing - Implanted mechanical aortic and/or mitral valve(s) and/or right heart valve(s) - Aortic valve closure - Hypertrophic obstructive cardiomyopathy or sarcoidosis - Left ventricular end-diastolic diameter below normal (restrictive cardiomyopathy) - Irreversible multi-organ failure - Diagnosis of psychiatric disease, irreversible cognitive dysfunction or poor psycho-social issues likely to impair compliance with study protocol - Any condition that could limit survival to less than 2 years - History of cardiac or other organ transplant - Contraindicated to anti-coagulation, antiplatelet therapy, or diagnosis of coagulation disorders - Require acute or chronic renal replacement therapy within 3 months prior to enrollment - Participation in any other clinical investigations involving another Mechanical Circulating Support device or HF-related drug - Active infection - History of recurrent (>1) pulmonary embolism or deep vein thrombosis - Unable to tolerate right heart catheterization - Implantation of cardiac re-synchronization therapy < 3 months before enrollment - Congenital heart disease - Hypersensitivity or allergy to aspirin and/or clopidogrel |
Country | Name | City | State |
---|---|---|---|
United States | Inova Heart and Vascular Institute | Falls Church | Virginia |
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
STAVROS G DRAKOS | Abbott |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects that meet explantation criteria by month 12 post-LVAD implantation, have LVAD explanted and retain left ventricular ejection fraction >=45% at 12 months post-LVAD weaning | Removal of LVAD happens when subject meets all five of the following explantation criteria: (1) left ventricular end-diastolic diameter < 60mm; (2) left ventricular end-systolic diameter < 50mm; (3) left ventricular ejection fraction > 45%; (4) left ventricular end-diastolic pressure <= 15 mmHg; (5) resting cardiac index > 2.4 L/min/m^2 | 24 months | |
Secondary | Hospital Admissions | Proportion of subjects admitted to the hospital for HF exacerbations at any time point during the study | 24 months | |
Secondary | Six-minute Walk Test | Subject performance during six-minute walk test at 12 months after LVAD implantation | 12 months |
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