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)
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Men or women, greater than or equal to18 to 85 years of age.
• NYHA Class II or III or NYHA class IV symptoms.
• A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
• Qualifying Baseline RHC.
• Qualifying echocardiogram
• Qualifying 6-MWD
• A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
• Requirements related to child bearing potential, contraception, and egg/sperm donation
Locations
United States
Alabama
Tenax Investigational Site
RECRUITING
Birmingham
Arkansas
Tenax Investigational Site
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Little Rock
Arizona
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Tucson
California
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Irvine
Tenax Investigational Site
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La Jolla
Tenax Investigational Site
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Los Angeles
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Los Angeles
Tenax Investigational Site
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Sacramento
Tenax Investigational Site
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San Francisco
Tenax Investigational Site
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Torrance
Washington, D.c.
Tenax Investigational Site
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Washington D.c.
Florida
Tenax Investigational Site
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Jacksonville
Tenax Investigational Site
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Tampa
Tenax Investigational Site
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Tampa
Tenax Investigational Site
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Winter Haven
Georgia
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Atlanta
Illinois
Tenax Investigational Site
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Chicago
Tenax Investigational Site
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Chicago
Tenax Investigational Site
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Galesburg
Tenax Investigational Site
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Oak Lawn
Indiana
Tenax Investigational Site
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Indianapolis
Tenax Investigational Site
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Indianapolis
Kansas
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Kansas City
Kentucky
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Louisville
Massachusetts
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Boston
Minnesota
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Minneapolis
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Rochester
Missouri
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St Louis
North Carolina
Tenax Investigational Site
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Charlotte
Tenax Investigational Site
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Durham
Tenax Investigational Site
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Greensboro
Nebraska
Tenax Investigational Site
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Omaha
New York
Tenax Investigational Site
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New York
Tenax Investigational Site
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New York
Tenax Investigational Site
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Rochester
Tenax Investigational Site
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Roslyn
Ohio
Tenax Investigational Site
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Cincinnati
Tenax Investigational Site
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Columbus
Pennsylvania
Tenax Investigational Site
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Philadelphia
Tenax Investigational Site
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Pittsburgh
Rhode Island
Tenax Investigational Site
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Providence
South Carolina
Tenax Investigational Site
RECRUITING
Charleston
Tenax Investigational Site
RECRUITING
Greenville
Tennessee
Tenax Investigational Site
RECRUITING
Nashville
Texas
Tenax Investigational Site
RECRUITING
Dallas
Tenax Investigational Site
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Dallas
Tenax Investigational Site
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Lubbock
Tenax Investigational Site
RECRUITING
Plano
Utah
Tenax Investigational Site
RECRUITING
Murray
Virginia
Tenax Investigational Site
RECRUITING
Richmond
Wisconsin
Tenax Investigational Site
RECRUITING
Madison
Other Locations
Canada
Tenax Investigational Site
RECRUITING
London
Tenax Investigational Site
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Toronto
Tenax Investigational Site
RECRUITING
Winnipeg
Contact Information
Primary
Kevin Crawford
k.crawford@tenaxthera.com
19198552145
Backup
Douglas Hay, PhD
d.hay@tenaxthera.com
19198552110
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2028-10
Participants
Target number of participants: 230
Treatments
Placebo_comparator: Placebo
Placebo
Active_comparator: TNX-103
oral levosimendan
Related Therapeutic Areas
Sponsors
Leads: Tenax Therapeutics, Inc.
Collaborators: Northwestern University, Medpace, Inc.