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

Recruiting · NCT07288398 · Interventional (participants receive a specific treatment) · Lead sponsor: Tenax Therapeutics, Inc.

View the official record on ClinicalTrials.gov →

Hypertension Heart failure

Interventions studied

PlaceboTNX-103

What this trial is about

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.

Who can take part

Age range

18 Years to 85 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Men or women, ≥18 to 85 years of age
NYHA Class II or III or ambulatory NYHA Class IV symptoms
A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
A qualifying baseline RHC
A qualifying echocardiogram
A 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)

Exclusion criteria

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

Where it is running

60 locations listed across 23 US states.

Tenax Investigational Site - Alexander City, Alabama, United States
Tenax Investigational Site - Alexander City, Alabama, United States
Tenax Investigational Site - Tucson, Arizona, United States
Tenax Investigational Site - Tucson, Arizona, United States
Tenax Investigational Site - Sacramento, California, United States
Tenax Investigational Site - Sacramento, California, United States
Tenax Investigational Site - San Francisco, California, United States
Tenax Investigational Site - San Francisco, California, United States
Tenax Investigational Site - Stanford, California, United States
Tenax Investigational Site - Stanford, California, United States
Tenax Investigational Site - Torrance, California, United States
Tenax Investigational Site - Torrance, California, United States
Tenax Investigational Site - Athens, Georgia, United States
Tenax Investigational Site - Athens, Georgia, United States
Tenax Investigational Site - Atlanta, Georgia, United States
Tenax Investigational Site - Atlanta, Georgia, United States
Tenax Investigational Site - Chicago, Illinois, United States
Tenax Investigational Site - Chicago, Illinois, United States
Tenax Investigational Site - Chicago, Illinois, United States
Tenax Investigational Site - Chicago, Illinois, United States
Tenax Investigational Site - Mount Prospect, Illinois, United States
Tenax Investigational Site - Mount Prospect, Illinois, United States
Tenax Investigational Site - Peoria, Illinois, United States
Tenax Investigational Site - Peoria, Illinois, United States
Tenax Investigational Site - Indianapolis, Indiana, United States
Tenax Investigational Site - Indianapolis, Indiana, United States
Tenax Investigational Site - New Orleans, Louisiana, United States
Tenax Investigational Site - New Orleans, Louisiana, United States
Tenax Investigational Site - West Monroe, Louisiana, United States
Tenax Investigational Site - West Monroe, Louisiana, United States
Tenax Investigational Site - Boston, Massachusetts, United States
Tenax Investigational Site - Boston, Massachusetts, United States
Tenax Investigational Site - Ann Arbor, Michigan, United States
Tenax Investigational Site - Ann Arbor, Michigan, United States
Tenax Investigational Site - Ypsilanti, Michigan, United States
Tenax Investigational Site - Ypsilanti, Michigan, United States
Tenax Investigational Site - Minneapolis, Minnesota, United States
Tenax Investigational Site - Minneapolis, Minnesota, United States
Tenax Investigational Site - Rochester, Minnesota, United States
Tenax Investigational Site - Rochester, Minnesota, United States
Tenax Investigational Site - Kansas City, Missouri, United States
Tenax Investigational Site - Kansas City, Missouri, United States
Tenax Investigational Site - St Louis, Missouri, United States
Tenax Investigational Site - St Louis, Missouri, United States
Tenax Investigational Site - Omaha, Nebraska, United States
Tenax Investigational Site - Omaha, Nebraska, United States
Tenax Investigational Site - Reno, Nevada, United States
Tenax Investigational Site - Reno, Nevada, United States
Tenax Investigational Site - New York, New York, United States
Tenax Investigational Site - New York, New York, United States
Tenax Investigational Site - New York, New York, United States
Tenax Investigational Site - New York, New York, United States
Tenax Investigational Site - Rochester, New York, United States
Tenax Investigational Site - Rochester, New York, United States
Tenax Investigational Site - Durham, North Carolina, United States
Tenax Investigational Site - Durham, North Carolina, United States
Tenax Investigational Site - Winston-Salem, North Carolina, United States
Tenax Investigational Site - Winston-Salem, North Carolina, United States
Tenax Investigational Site - Cleveland, Ohio, United States
Tenax Investigational Site - Cleveland, Ohio, United States

Showing 60 of 282 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →