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Clinical Trials in Canada / NCT05983250
Active, not recruiting Phase 3

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

NCT05983250 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2024-01-10
Last updated
2026-07-24

Condition(s) studied

Pulmonary Hypertension

Investigational drug(s) / intervention(s)

TNX-103 →Placebo

TNX-103: oral levosimendan 1 mg

Placebo: Placebo

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Tenax Investigational Site Tucson Arizona
Tenax Investigational Site La Jolla California
Tenax Investigational Site Los Angeles California
Tenax Investigational Site Los Angeles California
Tenax Investigational Site Sacramento California
Tenax Investigational Site San Francisco California
Tenax Investigational Site Torrance California
Tenax Investigational Site Jacksonville Florida
Tenax Investigational Site Winter Haven Florida
Tenax Investigational Site Atlanta Georgia
Tenax Investigational Site Chicago Illinois
Tenax Investigational Site Chicago Illinois
Tenax Investigational Site Galesburg Illinois
Tenax Investigational Site Indianapolis Indiana
Tenax Investigational Site Indianapolis Indiana
Tenax Investigational Site Louisville Kentucky
Tenax Investigational Site Boston Massachusetts
Tenax Investigational Site Minneapolis Minnesota
Tenax Investigational Site Rochester Minnesota
Tenax Investigational Site St Louis Missouri
Tenax Investigational Site Omaha Nebraska
Tenax Investigational Site New York New York
Tenax Investigational Site New York New York
Tenax Investigational Site Rochester New York
Tenax Investigational Site Roslyn New York
Tenax Investigational Site Durham North Carolina
Tenax Investigational Site Greensboro North Carolina
Tenax Investigational Site Cincinnati Ohio
Tenax Investigational Site Columbus Ohio
Tenax Investigational Site Pittsburgh Pennsylvania
Tenax Investigational Site Providence Rhode Island
Tenax Investigational Site Charleston South Carolina
Tenax Investigational Site Columbia South Carolina
Tenax Investigational Site Dallas Texas
Tenax Investigational Site Dallas Texas
Tenax Investigational Site Lubbock Texas
Tenax Investigational Site Plano Texas
Tenax Investigational Site Murray Utah
Tenax Investigational Site Richmond Virginia
Tenax Investigational Site Madison Wisconsin

+ 2 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05983250 on ClinicalTrials.gov ↗ ← All trials in Canada