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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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts 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 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

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		Matching placebo (oral)
  • Drug: Placebo
    Matching placebo (oral)
Active Comparator
TNX-103 		Oral levosimendan
  • Drug: TNX-103
    Oral levosimendan

Recruiting Locations

Tenax Investigational Site
Alexander City, Alabama 35010

Tenax Investigational Site
Peoria, Illinois 61636

Tenax Investigational Site
Indianapolis, Indiana 46260

Tenax Investigational Site
New Orleans, Louisiana 70115-6969

Tenax Investigational Site
West Monroe, Louisiana 71291

Tenax Investigational Site
Ypsilanti, Michigan 48197

Tenax Investigational Site
Omaha, Nebraska 68198

Tenax Investigational Site
Reno, Nevada 89502

Tenax Investigational Site
New York, New York 10021

Tenax Investigational Site
New York, New York 10032

Tenax Investigational Site
Rochester, New York 14617

Tenax Investigational Site
Durham, North Carolina 27710

Tenax Investigational Site
Winston-Salem, North Carolina 27101

Tenax Investigational Site
Nashville, Tennessee 37205

Tenax Investigational Site
Austin, Texas 78705

Tenax Investigational Site
Dallas, Texas 75390

Tenax Investigational Site
Marshfield, Wisconsin 54449

More Details

Status
Recruiting
Sponsor
Tenax Therapeutics, Inc.

Study Contact

Akshata Ashokkumar
(919) 855-2118
a.ashokkumar@tenaxthera.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.