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NCT07288398 · ClinicalTrials.gov registry record · Phase 3
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
A Phase 3 study of Pulmonary Hypertension Associated With HFpEF, sponsored by Tenax Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT07288398: Recruiting Phase 3 study of Pulmonary Hypertension Associated With HFpEF, sponsored by Tenax Therapeutics.
NCT07288398 is a Phase 3 study of Pulmonary Hypertension Associated With HFpEF that is actively recruiting participants, run by Tenax Therapeutics. The registered enrollment target is 540 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07288398, a Phase 3 study of Pulmonary Hypertension Associated With HFpEF, is actively recruiting participants, sponsored by Tenax Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Change in 6-minute walk distance
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TNX-103
Study Locations (20)
Texas
- Tenax Investigational Site - Austin
- Tenax Investigational Site - Dallas
- Tenax Investigational Site - Houston
Illinois
- Tenax Investigational Site - Mount Prospect
- Tenax Investigational Site - Peoria
Louisiana
- Tenax Investigational Site - New Orleans
- Tenax Investigational Site - West Monroe
Pennsylvania
- Tenax Investigational Site - Allentown
- Tenax Investigational Site - Wynnewood
Alabama
- Tenax Investigational Site - Alexander City
Florida
- Tenax Investigational Site - Tamarac
Michigan
- Tenax Investigational Site - Ypsilanti
Nevada
- Tenax Investigational Site - Reno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2026-03-03 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
What NCT07288398 shows while recruiting
NCT07288398 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Pulmonary Hypertension Associated With HFpEF appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07288398 names 20 study sites across 15 states, led by Texas, Illinois, Louisiana.
Frequently Asked Questions
What is clinical trial NCT07288398 about?
NCT07288398 is a clinical study titled "LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2". 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 Di...
What is the current status of trial NCT07288398?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2026-03-03. Estimated completion is 2029-06-30.
What conditions does trial NCT07288398 study?
This clinical trial studies the following conditions: Pulmonary Hypertension Associated With HFpEF.
What interventions are being tested in trial NCT07288398?
The interventions under investigation include: Placebo (DRUG), TNX-103 (DRUG).
Who is sponsoring clinical trial NCT07288398?
This trial is sponsored by Tenax Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07288398 being conducted?
This trial has 20 study locations across Alabama, Florida, Illinois, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07288398's enrollment target sits among peer trials
540 694th of 2000 higher than 1,302 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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