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Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
Sponsor: Tenax Therapeutics, Inc.
Summary
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
Official title: Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2019-04-09
Completion Date
2023-04-25
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
Levosimendan
Initial: 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 a weekly 24 hour infusion. Transioned to: Daily Levosimendan capsules (1 mg TID)
Locations (9)
Stanford Healthcare
Stanford, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
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