NCT07288398

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Tenax Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.

Conditions

• Pulmonary Hypertension Associated With HFpEF

Interventions

Type	Name	Description
DRUG	TNX-103	Oral levosimendan
DRUG	Placebo	Matching placebo (oral)

Timeline

• Start date: 2026-03-03
• Primary completion: 2028-06-30
• Completion: 2029-06-30
• First posted: 2025-12-17
• Last updated: 2026-03-16

Locations

92 sites across 15 countries: United States, Argentina, Austria, Brazil, Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study