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LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

NCT05983250 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-02-18

No results posted yet for this study

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).

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

TNX-103

oral levosimendan 1 mg

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Northwestern University

    collaborator OTHER

  • Tenax Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2026-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983250 on ClinicalTrials.gov