Study of LEVOSIMENDAN for Exercise Limitation in PH-HFpEF
This study is testing an oral medication called TNX-103 (levosimendan) to see if it can improve how far people with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) can walk in six minutes. PH-HFpEF is a condition where high blood pressure in the lungs makes it hard to exercise. We are looking for about 230 adults, aged 18 to 85, who have been diagnosed with this condition and meet specific heart health criteria. The main goal is to see if TNX-103 helps you walk further over 12 weeks compared to a placebo (an inactive pill). The current status of this study is unclear.
- Study design
- This is a Phase 3, double-blind, randomized study, meaning neither you nor your doctor will know if you're receiving TNX-103 or a placebo. Approximately 230 participants will be involved.
- What's involved
- You would go through a screening period of up to 30 days, followed by a 12-week treatment phase. You will also have a 48-hour heart rhythm monitor during screening.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 12-week treatment, you may have the option to join an open-label extension for an additional 92 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.
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
At a glance
Conditions
Where it's being run
42 sites across 23 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change in Six-minute walk distance12 weeks