LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Purpose
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.
Condition
- Pulmonary Hypertension Associated With HFpEF
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Men or women, ≥18 to 85 years of age 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC) 4. A qualifying baseline RHC 5. A qualifying echocardiogram 6. A 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
- 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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Matching placebo (oral) |
|
|
Active Comparator TNX-103 |
Oral levosimendan |
|
Recruiting Locations
Tenax Investigational Site
Alexander City, Alabama 35010
Alexander City, Alabama 35010
Tenax Investigational Site
Peoria, Illinois 61636
Peoria, Illinois 61636
Tenax Investigational Site
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Tenax Investigational Site
New Orleans, Louisiana 70115-6969
New Orleans, Louisiana 70115-6969
Tenax Investigational Site
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
Tenax Investigational Site
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Tenax Investigational Site
Omaha, Nebraska 68198
Omaha, Nebraska 68198
Tenax Investigational Site
Reno, Nevada 89502
Reno, Nevada 89502
Tenax Investigational Site
New York, New York 10021
New York, New York 10021
Tenax Investigational Site
New York, New York 10032
New York, New York 10032
Tenax Investigational Site
Rochester, New York 14617
Rochester, New York 14617
Tenax Investigational Site
Durham, North Carolina 27710
Durham, North Carolina 27710
Tenax Investigational Site
Winston-Salem, North Carolina 27101
Winston-Salem, North Carolina 27101
Tenax Investigational Site
Nashville, Tennessee 37205
Nashville, Tennessee 37205
Tenax Investigational Site
Austin, Texas 78705
Austin, Texas 78705
Tenax Investigational Site
Dallas, Texas 75390
Dallas, Texas 75390
Tenax Investigational Site
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
More Details
- Status
- Recruiting
- Sponsor
- Tenax Therapeutics, Inc.
Detailed Description
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.