drugset / Trial / NCT07288398

LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

NCT07288398

Phase 3 Recruiting 540 enrolled Tenax Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-03-03
Primary completion
2028-06-30
Completion
2029-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levosimendan Other / unclassified Oral