PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
Stanford Healthcare
Stanford, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Clinical Safety measured by number of adverse events (AEs )
Long-term safety profile of levosimendan measured by number of adverse events (AEs )
Time frame: 2 years
6-minute walk test (6MWT)
Exercise capacity, measured as a distance traveled in 6 minutes
Time frame: 2 years
Patient global assessment
Patient's assessment of well-being, based on a six-point Likert scale (1 =worst, 5= best)
Time frame: 2 years
Physician's Assessment of Functional Class
Physician's Assessment of New York Heart Association (NYHA) Classification (one of four categories based on how much the patient is limited during physical activity. (Class I, no limitation of physical activity to Class IV, marked limitation of physical activity)
Time frame: 2 years
Clinical Events: Death and hospitalizations
Incidence of death or hospitalization
Time frame: 2 years
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Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UW Health University Hospital
Madison, Wisconsin, United States