LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
LEVEL
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)
1 other identifier
interventional
230
2 countries
44
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2024
Longer than P75 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 9, 2023
CompletedStudy Start
First participant enrolled
January 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
February 18, 2026
December 1, 2025
2.7 years
August 1, 2023
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Six-minute walk distance
12 weeks
Secondary Outcomes (4)
KCCQ
12 weeks
Clinical Worsening Events
12 weeks
Change in NT-proBNP
12 weeks
Change NYHA functional class
12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
TNX-103
ACTIVE COMPARATORoral levosimendan
Interventions
Eligibility Criteria
You may qualify if:
- Men or women, greater than or equal to18 to 85 years of age.
- NYHA Class II or III or NYHA class IV symptoms.
- A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- Qualifying Baseline RHC.
- Qualifying echocardiogram
- Qualifying 6-MWD
- A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
- Requirements related to child bearing potential, contraception, and egg/sperm donation
You may not qualify if:
- A diagnosis of PH WHO Groups 1, 3, 4, or 5.
- Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- 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
- A diagnosis of pre-existing lung disease
- History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
- Major surgery within 60 days.
- Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months
- History of clinically significant other diseases that may limit or complicate participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tenax Therapeutics, Inc.lead
- Medpace, Inc.collaborator
- Northwestern Universitycollaborator
Study Sites (44)
Tenax Investigational Site
Tucson, Arizona, 85721, United States
Tenax Investigational Site
La Jolla, California, 92037, United States
Tenax Investigational Site
Los Angeles, California, 90033, United States
Tenax Investigational Site
Los Angeles, California, 90048, United States
Tenax Investigational Site
Sacramento, California, 95817, United States
Tenax Investigational Site
San Francisco, California, 94143, United States
Tenax Investigational Site
Torrance, California, 90502, United States
Tenax Investigational Site
Jacksonville, Florida, 32224, United States
Tenax Investigational Site
Winter Haven, Florida, 33881, United States
Tenax Investigational Site
Atlanta, Georgia, 30322, United States
Tenax Investigational Site
Chicago, Illinois, 60208, United States
Tenax Investigational Site
Chicago, Illinois, 60637, United States
Tenax Investigational Site
Galesburg, Illinois, 61401, United States
Tenax Investigational Site
Indianapolis, Indiana, 46202, United States
Tenax Investigational Site
Indianapolis, Indiana, 46260, United States
Tenax Investigational Site
Louisville, Kentucky, 40202, United States
Tenax Investigational Site
Boston, Massachusetts, 02114, United States
Tenax Investigational Site
Minneapolis, Minnesota, 55455, United States
Tenax Investigational Site
Rochester, Minnesota, 55905, United States
Tenax Investigational Site
St Louis, Missouri, 63136, United States
Tenax Investigational Site
Omaha, Nebraska, 68198, United States
Tenax Investigational Site
New York, New York, 10021, United States
Tenax Investigational Site
New York, New York, 10029, United States
Tenax Investigational Site
Rochester, New York, 14621, United States
Tenax Investigational Site
Roslyn, New York, 11576, United States
Tenax Investigational Site
Charlotte, North Carolina, 28203, United States
Tenax Investigational Site
Durham, North Carolina, 27710, United States
Tenax Investigational Site
Greensboro, North Carolina, 27401, United States
Tenax Investigational Site
Cincinnati, Ohio, 45267, United States
Tenax Investigational Site
Columbus, Ohio, 43214, United States
Tenax Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
Tenax Investigational Site
Providence, Rhode Island, 02903, United States
Tenax Investigational Site
Charleston, South Carolina, 29425, United States
Tenax Investigational Site
Columbia, South Carolina, 29044, United States
Tenax Investigational Site
Dallas, Texas, 75204, United States
Tenax Investigational Site
Dallas, Texas, 75390, United States
Tenax Investigational Site
Lubbock, Texas, 79430, United States
Tenax Investigational Site
Plano, Texas, 75093, United States
Tenax Investigational Site
Murray, Utah, 84107, United States
Tenax Investigational Site
Richmond, Virginia, 23298, United States
Tenax Investigational Site
Madison, Wisconsin, 53792, United States
Tenax Investigational Site
Winnipeg, Manitoba, Canada
Tenax Investigational Site
London, Ontario, N6A 5A5, Canada
Tenax Investigational Site
Toronto, Ontario, M5A 4P5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The blind is maintained by the use of a matching placebo.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 9, 2023
Study Start
January 10, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
February 18, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share