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LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

NCT ID: NCT05983250

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2028-10-31

Brief Summary

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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

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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

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Pulmonary Hypertension

Keywords

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HFpEF Pulmonary hypertension group 2 PH-HFpEF Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, randomized, placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The blind is maintained by the use of a matching placebo.

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

TNX-103

oral levosimendan

Group Type ACTIVE_COMPARATOR

TNX-103

Intervention Type DRUG

oral levosimendan 1 mg

Interventions

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TNX-103

oral levosimendan 1 mg

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

Tenax Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tenax Investigational Site

Tucson, Arizona, United States

Site Status RECRUITING

Tenax Investigational Site

La Jolla, California, United States

Site Status RECRUITING

Tenax Investigational Site

Los Angeles, California, United States

Site Status RECRUITING

Tenax Investigational Site

Los Angeles, California, United States

Site Status RECRUITING

Tenax Investigational Site

Sacramento, California, United States

Site Status RECRUITING

Tenax Investigational Site

San Francisco, California, United States

Site Status RECRUITING

Tenax Investigational Site

Torrance, California, United States

Site Status RECRUITING

Tenax Investigational Site

Jacksonville, Florida, United States

Site Status RECRUITING

Tenax Investigational Site

Tampa, Florida, United States

Site Status RECRUITING

Tenax Investigational Site

Tampa, Florida, United States

Site Status RECRUITING

Tenax Investigational Site

Winter Haven, Florida, United States

Site Status RECRUITING

Tenax Investigational Site

Atlanta, Georgia, United States

Site Status RECRUITING

Tenax Investigational Site

Chicago, Illinois, United States

Site Status RECRUITING

Tenax Investigational Site

Chicago, Illinois, United States

Site Status RECRUITING

Tenax Investigational Site

Galesburg, Illinois, United States

Site Status RECRUITING

Tenax Investigational Site

Indianapolis, Indiana, United States

Site Status RECRUITING

Tenax Investigational Site

Indianapolis, Indiana, United States

Site Status RECRUITING

Tenax Investigational Site

Kansas City, Kansas, United States

Site Status RECRUITING

Tenax Investigational Site

Louisville, Kentucky, United States

Site Status RECRUITING

Tenax Investigational Site

Boston, Massachusetts, United States

Site Status RECRUITING

Tenax Investigational Site

Minneapolis, Minnesota, United States

Site Status RECRUITING

Tenax Investigational Site

Rochester, Minnesota, United States

Site Status RECRUITING

Tenax Investigational Site

St Louis, Missouri, United States

Site Status RECRUITING

Tenax Investigational Site

Omaha, Nebraska, United States

Site Status RECRUITING

Tenax Investigational Site

New York, New York, United States

Site Status RECRUITING

Tenax Investigational Site

New York, New York, United States

Site Status RECRUITING

Tenax Investigational Site

Rochester, New York, United States

Site Status RECRUITING

Tenax Investigational Site

Roslyn, New York, United States

Site Status RECRUITING

Tenax Investigational Site

Charlotte, North Carolina, United States

Site Status RECRUITING

Tenax Investigational Site

Durham, North Carolina, United States

Site Status RECRUITING

Tenax Investigational Site

Greensboro, North Carolina, United States

Site Status RECRUITING

Tenax Investigational Site

Cincinnati, Ohio, United States

Site Status RECRUITING

Tenax Investigational Site

Columbus, Ohio, United States

Site Status RECRUITING

Tenax Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Tenax Investigational Site

Providence, Rhode Island, United States

Site Status RECRUITING

Tenax Investigational Site

Charleston, South Carolina, United States

Site Status RECRUITING

Tenax Investigational Site

Columbia, South Carolina, United States

Site Status RECRUITING

Tenax Investigational Site

Dallas, Texas, United States

Site Status RECRUITING

Tenax Investigational Site

Dallas, Texas, United States

Site Status RECRUITING

Tenax Investigational Site

Lubbock, Texas, United States

Site Status RECRUITING

Tenax Investigational Site

Plano, Texas, United States

Site Status RECRUITING

Tenax Investigational Site

Murray, Utah, United States

Site Status RECRUITING

Tenax Investigational Site

Richmond, Virginia, United States

Site Status RECRUITING

Tenax Investigational Site

Madison, Wisconsin, United States

Site Status RECRUITING

Tenax Investigational Site

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Tenax Investigational Site

London, Ontario, Canada

Site Status RECRUITING

Tenax Investigational Site

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Kevin Crawford

Role: CONTACT

Phone: 19198552145

Email: [email protected]

Douglas Hay, PhD

Role: CONTACT

Phone: 19198552110

Email: [email protected]

Other Identifiers

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TNX-103-06

Identifier Type: -

Identifier Source: org_study_id