Oral Levosimendan for Pulmonary Hypertension with Heart Failure

This study is testing an oral medication called levosimendan (TNX-103) against a placebo (an inactive pill) to see if it can help people with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). This condition means you have high blood pressure in the arteries of your lungs and your heart can't relax properly to fill with blood. The study aims to see if levosimendan improves how far you can walk in 6 minutes. You might be able to join if you are between 18 and 85 years old and have been diagnosed with this specific type of PH-HFpEF. The study is currently recruiting participants.

Study design
Approximately 540 participants will be randomly assigned to receive either oral levosimendan or a matching placebo. Participants may also be eligible for an open-label extension for 52 weeks.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, 6-Minute Walk Distance, is measured at 26 weeks. Participants may be eligible for an open-label extension of 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07288398

LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

Recruiting
PHASE3Ages 18–85InterventionalTreatment
Tenax Therapeutics, Inc.
~540 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:TNX-103Placebo

At a glance

Recruiting sites
48 of 141 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-Minute Walk Distance (6MWD)
Measured over 26 weeks
Pulmonary Hypertension Associated With HFpEF
141 sites across 45 states
Spain15
Italy10
Argentina7
Germany7
Bulgaria6
France6
South Korea6
Taiwan6

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  • 6-Minute Walk Distance (6MWD)26 weeks

    Change in 6-minute walk distance