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

NCT07288398 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Pulmonary Hypertension Associated With HFpEF

Interventions

DRUG

TNX-103

Oral levosimendan

DRUG

Placebo

Matching placebo (oral)

Sponsors & Collaborators

  • 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
2026-03-03
Primary Completion
2028-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT07288398 on ClinicalTrials.gov