A Phase 3 interventional study of TNX-103 and Placebo in Pulmonary Hypertension Associated With HFpEF, sponsored by Tenax Therapeutics, Inc.. Recruiting at 141 sites in 15 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Tenax Therapeutics, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 540 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Tenax Therapeutics, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Matching placebo (oral)
Drug: Placebo
Oral levosimendan
Drug: TNX-103
Oral levosimendan
Matching placebo (oral)
6-Minute Walk Distance (6MWD)
Change in 6-minute walk distance
Time frame: 26 weeks
KCCQ (Kansas City Cardiomyopathy Questionnaire) score is a standardized measure that ranges from 0 to 100, where a higher score indicates better health.
Change in KCCQ Total Symptom Score
Time frame: 26 weeks
Clinical Worsening Events
Number of Clinical Worsening Events
Time frame: 26 weeks
Clinical Worsening Event
Time to first occurrence of a Clinical Worsening Event
Time frame: 26 weeks
NYHA (New York Heart Association) classification assesses and categorizes a patient's physical ability and symptoms into four classes, the lower the classification, the least impact on physical activity.
Change in NYHA Functional Class
Time frame: 26 weeks
Showing the first 100 of 141 sites across 15 countries.
Plan to share: No
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Tenax Therapeutics, Inc.