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COMPLETED
NCT03624010
PHASE2

Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients

Sponsor: Tenax Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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