NCT05983250

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Tenax Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	TNX-103	oral levosimendan 1 mg
DRUG	Placebo	Placebo

Timeline

• Start date: 2024-01-10
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2023-08-09
• Last updated: 2026-02-18

Locations

44 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study