The purpose of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function after undergoing a standardized Left Ventricular Assist Device (LVAD) plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months.
The encouraging results from the LVAD based recovery series suggest that the significant hemodynamic unloading provided by the Mechanical Circulatory Support (MCS) in conjunction with aggressive pharmacological treatment may induce a profound reverse structural remodeling and in turn result in a curative alternative to a specific patient population with severe heart failure. The active identification and characterization of the patients with a high potential for full cardiac function recovery is of paramount importance. The development of a standard and simplified recovery protocol would ultimately lead to a larger bridge to recovery patient population. The primary objective of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function (remission from heart failure) after undergoing a standardized LVAD plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months. The secondary objectives of this study are twofold, first to determine the durability of sustained remission from HF following LVAD explantation at 12 months and up to 3 years and second to determine the predictors of recovery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ recovery and titrated (against symptoms, potassium, and renal function) to the following maximum doses: lisinopril 40 mg daily; carvedilol 25 mg 3 times daily; spironolactone 25 mg daily; digoxin 125g daily, and losartan 150 mg daily.
University of Louisville
Louisville, Kentucky, United States
RECRUITINGUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGMontefiore Medical Center
New York, New York, United States
Proportion of subjects who experience LVAD removal and subsequent freedom from mechanical circulatory support or heart transplantation
Time frame: 12 months
The proportion of evaluable subjects meeting explant criteria and subsequently explanted
Time frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months
The time course of reverse remodeling on a left ventricular assist device
Time frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months
The time course and sustainability of reverse remodeling following LVAD explantation
Time frame: 12-18 months
Predictors of recovery and device removal
Time frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months
Changes in maximal and sub maximal exercise capacity
Time frame: 12-18 months
Changes in renal function and hepatic enzymes
Time frame: 6 weeks, 3, 4, 5, 6, 9, 12-18 months
Changes in EF measured at 6000RPM.
Time frame: 6 weeks, 4, 6, 9, 12-18 months
Changes in quality of life, as measured by the EuroQoL (EQ5D)
Time frame: 6 months
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Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Utah
Salt Lake City, Utah, United States
RECRUITING