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.

NCT05983250

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Active, Not Recruiting
PHASE3Ages 18–85InterventionalTreatment
Tenax Therapeutics, Inc.
~230 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:TNX-103Placebo

At a glance

Recruiting sites
0 of 42 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Six-minute walk distance
Measured over 12 weeks
Pulmonary Hypertension
42 sites across 23 states
California6
New York4
Texas4
Illinois3
Florida2
Indiana2
Minnesota2
North Carolina2

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Change in Six-minute walk distance12 weeks