A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction
Tenax Therapeutics, Inc.
Summary
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.
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.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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: 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5 2. Echocardiographic…
Interventions
- DrugTNX-103
Oral levosimendan
- DrugPlacebo
Matching placebo (oral)
Locations (92)
- Tenax Investigational SiteAlexander City, Alabama
- Tenax Investigational SiteTamarac, Florida
- Tenax Investigational SiteMount Prospect, Illinois
- Tenax Investigational SitePeoria, Illinois
- Tenax Investigational SiteNew Orleans, Louisiana
- Tenax Investigational SiteWest Monroe, Louisiana