Pulmonary Hypertension (PH) with Heart Failure with preserved left ventricular ejection fraction (PH-HFpEF)
Conditions
Brief summary
Efficacy: Change from baseline in 6-MWD (Day 1 to Week 26). Safety: Incidence of AEs, SAEs, physical examinations, vital signs, clinical laboratory values, ECGs, heart rate and rhythm as determined by cardiac monitoring and AESI (Day 1 to Week 26)
Detailed description
1. Change in KCCQ-TSS (Day 1 to Week 26)., 2. Number of Clinical Worsening Events (Day 1 to Week 26). Clinical Worsening Events are defined as: a. Unplanned hospitalization due to a cardiopulmonary indication OR Urgent outpatient visits for the administration of IV diuretics. b. Deaths (caused by clinical conditions directly related to cardiovascular events)., 3. Time to first occurrence of a Clinical Worsening Event (Day 1 to Week 26)., 4. Change in NYHA Functional Class (Day 1 to Week 26).
Interventions
DRUGThe levosimendan placebo drug product is an immediate-release dosage form for oral
administration.
DRUGLevosimendan
Sponsors
Tenax Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Change from baseline in 6-MWD (Day 1 to Week 26). Safety: Incidence of AEs, SAEs, physical examinations, vital signs, clinical laboratory values, ECGs, heart rate and rhythm as determined by cardiac monitoring and AESI (Day 1 to Week 26) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in KCCQ-TSS (Day 1 to Week 26)., 2. Number of Clinical Worsening Events (Day 1 to Week 26). Clinical Worsening Events are defined as: a. Unplanned hospitalization due to a cardiopulmonary indication OR Urgent outpatient visits for the administration of IV diuretics. b. Deaths (caused by clinical conditions directly related to cardiovascular events)., 3. Time to first occurrence of a Clinical Worsening Event (Day 1 to Week 26)., 4. Change in NYHA Functional Class (Day 1 to Week 26). | — |
Outcome results
None listed