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LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
Sponsor: Tenax Therapeutics, Inc.
Summary
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2024-01-10
Completion Date
2028-10
Last Updated
2026-02-18
Healthy Volunteers
No
Conditions
Interventions
TNX-103
oral levosimendan 1 mg
Placebo
Placebo
Locations (44)
Tenax Investigational Site
Tucson, Arizona, United States
Tenax Investigational Site
La Jolla, California, United States
Tenax Investigational Site
Los Angeles, California, United States
Tenax Investigational Site
Los Angeles, California, United States
Tenax Investigational Site
Sacramento, California, United States
Tenax Investigational Site
San Francisco, California, United States
Tenax Investigational Site
Torrance, California, United States
Tenax Investigational Site
Jacksonville, Florida, United States
Tenax Investigational Site
Winter Haven, Florida, United States
Tenax Investigational Site
Atlanta, Georgia, United States
Tenax Investigational Site
Chicago, Illinois, United States
Tenax Investigational Site
Chicago, Illinois, United States
Tenax Investigational Site
Galesburg, Illinois, United States
Tenax Investigational Site
Indianapolis, Indiana, United States
Tenax Investigational Site
Indianapolis, Indiana, United States
Tenax Investigational Site
Louisville, Kentucky, United States
Tenax Investigational Site
Boston, Massachusetts, United States
Tenax Investigational Site
Minneapolis, Minnesota, United States
Tenax Investigational Site
Rochester, Minnesota, United States
Tenax Investigational Site
St Louis, Missouri, United States
Tenax Investigational Site
Omaha, Nebraska, United States
Tenax Investigational Site
New York, New York, United States
Tenax Investigational Site
New York, New York, United States
Tenax Investigational Site
Rochester, New York, United States
Tenax Investigational Site
Roslyn, New York, United States
Tenax Investigational Site
Charlotte, North Carolina, United States
Tenax Investigational Site
Durham, North Carolina, United States
Tenax Investigational Site
Greensboro, North Carolina, United States
Tenax Investigational Site
Cincinnati, Ohio, United States
Tenax Investigational Site
Columbus, Ohio, United States
Tenax Investigational Site
Pittsburgh, Pennsylvania, United States
Tenax Investigational Site
Providence, Rhode Island, United States
Tenax Investigational Site
Charleston, South Carolina, United States
Tenax Investigational Site
Columbia, South Carolina, United States
Tenax Investigational Site
Dallas, Texas, United States
Tenax Investigational Site
Dallas, Texas, United States
Tenax Investigational Site
Lubbock, Texas, United States
Tenax Investigational Site
Plano, Texas, United States
Tenax Investigational Site
Murray, Utah, United States
Tenax Investigational Site
Richmond, Virginia, United States
Tenax Investigational Site
Madison, Wisconsin, United States
Tenax Investigational Site
Winnipeg, Manitoba, Canada
Tenax Investigational Site
London, Ontario, Canada
Tenax Investigational Site
Toronto, Ontario, Canada