Clinical Trial

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Study acronym: LEVEL
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-22
notable Primary completion moved earlier: 2026-10 -> 2026-06-16 2026-07-22
Trial Details
NCT Number NCT05983250
Lead Sponsor Tenax Therapeutics, Inc.
Collaborators: Medpace, Inc., Northwestern University
Conditions Pulmonary Hypertension
Enrollment 230 participants
Start Date 2024-01-10
Primary Completion 2026-06-30 (estimated)
Study Completion 2028-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-24