Pulmonary Hypertension Associated With HFpEF
Conditions
Keywords
PH-HFpEF, levosimendan, HFpEF, Heart Failure, Pulmonary Hypertension Group 2
Brief 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.
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.
Interventions
DRUGTNX-103
Oral levosimendan
DRUGPlacebo
Matching placebo (oral)
Sponsors
Tenax Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Distance (6MWD) | 26 weeks | Change in 6-minute walk distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KCCQ (Kansas City Cardiomyopathy Questionnaire) score is a standardized measure that ranges from 0 to 100, where a higher score indicates better health. | 26 weeks | Change in KCCQ Total Symptom Score |
| Clinical Worsening Events | 26 weeks | Number of Clinical Worsening Events |
| Clinical Worsening Event | 26 weeks | Time to first occurrence of a Clinical Worsening Event |
| NYHA (New York Heart Association) classification assesses and categorizes a patient's physical ability and symptoms into four classes, the lower the classification, the least impact on physical activity. | 26 weeks | Change in NYHA Functional Class |
Countries
Argentina, Austria, Brazil, Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTAkshata Ashokkumar
CONTACTKatelyn Jansson
Outcome results
None listed