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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 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. The trial reports 20 study locations across 15 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07288398
The ClinicalTrials.gov registry entry for NCT07288398 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tenax Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Related
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