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.
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
At a glance
Conditions
Where it's being run
141 sites across 45 statesWho to contact
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What this trial measures
- 6-Minute Walk Distance (6MWD)26 weeks
Change in 6-minute walk distance