LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

February 13, 2026 updated by: Tenax Therapeutics, Inc.

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Recruiting
        • Tenax Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • Tenax Investigational Site
      • Toronto, Ontario, Canada, M5A 4P5
        • Recruiting
        • Tenax Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Recruiting
        • Tenax Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Tenax Investigational Site
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Tenax Investigational Site
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Tenax Investigational Site
      • Sacramento, California, United States, 95817
        • Recruiting
        • Tenax Investigational Site
      • San Francisco, California, United States, 94143
        • Recruiting
        • Tenax Investigational Site
      • Torrance, California, United States, 90502
        • Recruiting
        • Tenax Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Tenax Investigational Site
      • Winter Haven, Florida, United States, 33881
        • Recruiting
        • Tenax Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Tenax Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60208
        • Recruiting
        • Tenax Investigational Site
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Tenax Investigational Site
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Tenax Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Tenax Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Tenax Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Tenax Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Tenax Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Tenax Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Tenax Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Tenax Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Tenax Investigational Site
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Tenax Investigational Site
      • New York, New York, United States, 10029
        • Recruiting
        • Tenax Investigational Site
      • Rochester, New York, United States, 14621
        • Recruiting
        • Tenax Investigational Site
      • Roslyn, New York, United States, 11576
        • Recruiting
        • Tenax Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Tenax Investigational Site
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Tenax Investigational Site
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Tenax Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Tenax Investigational Site
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Tenax Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Tenax Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Tenax Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Tenax Investigational Site
      • Columbia, South Carolina, United States, 29044
        • Recruiting
        • Tenax Investigational Site
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Tenax Investigational Site
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Tenax Investigational Site
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • Tenax Investigational Site
      • Plano, Texas, United States, 75093
        • Recruiting
        • Tenax Investigational Site
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Tenax Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Tenax Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • Tenax Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men or women, greater than or equal to18 to 85 years of age.
  2. NYHA Class II or III or NYHA class IV symptoms.
  3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
  4. Qualifying Baseline RHC.
  5. Qualifying echocardiogram
  6. Qualifying 6-MWD
  7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
  8. Requirements related to child bearing potential, contraception, and egg/sperm donation

Exclusion Criteria:

  1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.
  2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  3. Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous). OR, planned valve intervention. OR, the presence of significant valve disease
  4. A diagnosis of pre-existing lung disease
  5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
  6. Major surgery within 60 days.
  7. Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
  8. History of clinically significant other diseases that may limit or complicate participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Active Comparator: TNX-103
oral levosimendan
Drug: TNX-103
oral levosimendan 1 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Six-minute walk distance
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Worsening Events
Time Frame: 12 weeks
12 weeks
Change NYHA functional class
Time Frame: 12 weeks
On a scale of I-IV. Lower scores may indicate improvement in symptoms
12 weeks
KCCQ
Time Frame: 12 weeks
Change in KCCQ
12 weeks
Change in NT-proBNP
Time Frame: 12 weeks
Decreases in NT-proBNP may indicate an improvement in symptoms
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tenax Therapeutics, Inc.

Collaborators

Northwestern University
Medpace, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNX-103-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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