Actively Recruiting
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
Led by Tenax Therapeutics, Inc. · Updated on 2026-02-18
230
Participants Needed
44
Research Sites
246 weeks
Total Duration
On this page
Sponsors
T
Tenax Therapeutics, Inc.
Lead Sponsor
M
Medpace, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 to 85 years
- New York Heart Association (NYHA) Class II, III, or IV symptoms
- Diagnosed with World Health Organization Group 2 pulmonary hypertension with heart failure and preserved ejection fraction (PH-HFpEF) confirmed by qualifying hemodynamic tests
- Qualifying baseline right heart catheterization (RHC)
- Qualifying echocardiogram
- Qualifying 6-minute walk distance test
- Completion of a 48-hour ambulatory cardiac rhythm monitor during screening
- Compliance with childbearing potential, contraception, and egg/sperm donation requirements
You will not qualify if you...
- Diagnosis of pulmonary hypertension WHO Groups 1, 3, 4, or 5
- Echocardiographic evidence of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- Structural heart repair or valve replacement of aortic or mitral valves, planned valve intervention, or significant valve disease
- Pre-existing lung disease
- History of severe allergic or anaphylactic reaction or hypersensitivity to components of the study drug
- Major surgery within 60 days prior to screening
- Prior heart, lung, or heart-lung transplant or life expectancy less than 12 months
- History of other significant diseases that may limit or complicate study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
Tenax Investigational Site
Tucson, Arizona, United States, 85721
Actively Recruiting
2
Tenax Investigational Site
La Jolla, California, United States, 92037
Actively Recruiting
3
Tenax Investigational Site
Los Angeles, California, United States, 90033
Actively Recruiting
4
Tenax Investigational Site
Los Angeles, California, United States, 90048
Actively Recruiting
5
Tenax Investigational Site
Sacramento, California, United States, 95817
Actively Recruiting
6
Tenax Investigational Site
San Francisco, California, United States, 94143
Actively Recruiting
7
Tenax Investigational Site
Torrance, California, United States, 90502
Actively Recruiting
8
Tenax Investigational Site
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
Tenax Investigational Site
Winter Haven, Florida, United States, 33881
Actively Recruiting
10
Tenax Investigational Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
11
Tenax Investigational Site
Chicago, Illinois, United States, 60208
Actively Recruiting
12
Tenax Investigational Site
Chicago, Illinois, United States, 60637
Actively Recruiting
13
Tenax Investigational Site
Galesburg, Illinois, United States, 61401
Actively Recruiting
14
Tenax Investigational Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
15
Tenax Investigational Site
Indianapolis, Indiana, United States, 46260
Actively Recruiting
16
Tenax Investigational Site
Louisville, Kentucky, United States, 40202
Actively Recruiting
17
Tenax Investigational Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
18
Tenax Investigational Site
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
19
Tenax Investigational Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
20
Tenax Investigational Site
St Louis, Missouri, United States, 63136
Actively Recruiting
21
Tenax Investigational Site
Omaha, Nebraska, United States, 68198
Actively Recruiting
22
Tenax Investigational Site
New York, New York, United States, 10021
Actively Recruiting
23
Tenax Investigational Site
New York, New York, United States, 10029
Actively Recruiting
24
Tenax Investigational Site
Rochester, New York, United States, 14621
Actively Recruiting
25
Tenax Investigational Site
Roslyn, New York, United States, 11576
Actively Recruiting
26
Tenax Investigational Site
Charlotte, North Carolina, United States, 28203
Actively Recruiting
27
Tenax Investigational Site
Durham, North Carolina, United States, 27710
Actively Recruiting
28
Tenax Investigational Site
Greensboro, North Carolina, United States, 27401
Actively Recruiting
29
Tenax Investigational Site
Cincinnati, Ohio, United States, 45267
Actively Recruiting
30
Tenax Investigational Site
Columbus, Ohio, United States, 43214
Actively Recruiting
31
Tenax Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
32
Tenax Investigational Site
Providence, Rhode Island, United States, 02903
Actively Recruiting
33
Tenax Investigational Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
34
Tenax Investigational Site
Columbia, South Carolina, United States, 29044
Actively Recruiting
35
Tenax Investigational Site
Dallas, Texas, United States, 75204
Actively Recruiting
36
Tenax Investigational Site
Dallas, Texas, United States, 75390
Actively Recruiting
37
Tenax Investigational Site
Lubbock, Texas, United States, 79430
Actively Recruiting
38
Tenax Investigational Site
Plano, Texas, United States, 75093
Actively Recruiting
39
Tenax Investigational Site
Murray, Utah, United States, 84107
Actively Recruiting
40
Tenax Investigational Site
Richmond, Virginia, United States, 23298
Actively Recruiting
41
Tenax Investigational Site
Madison, Wisconsin, United States, 53792
Actively Recruiting
42
Tenax Investigational Site
Winnipeg, Manitoba, Canada
Actively Recruiting
43
Tenax Investigational Site
London, Ontario, Canada, N6A 5A5
Actively Recruiting
44
Tenax Investigational Site
Toronto, Ontario, Canada, M5A 4P5
Actively Recruiting
Research Team
K
Kevin Crawford
CONTACT
D
Douglas Hay, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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