Clinical Trial

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

Study acronym: LEVEL-2
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-15.
Trial Details
NCT Number NCT07288398
Lead Sponsor Tenax Therapeutics, Inc.
Conditions Pulmonary Hypertension Associated With HFpEF
Enrollment 540 participants
Start Date 2026-03-03
Primary Completion 2028-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-16