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Levosimendan in PH-HFpEF
NCT05983250Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jan 2024
- Primary completion
- Jun 2026
- Countries
- 2
- Sponsor
- Tenax Therapeutics
- Modality
- Small Molecules
- Drugs
- levosimendan
- Conditions
- pulmonary hypertension (PH)heart failure with preserved ejection fraction (HFpEF)
01
Overview
Phase 3, randomised, double-blind trial of levosimendan in pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) (2 arms), sponsored by Tenax Therapeutics. Primary endpoint: Six-Minute Walk Distance at 12 weeks. Started Jan 2024; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo
TNX-103
Oral levosimendan 1 mg
03
Who it enrols
Adults aged 18-85 with WHO Group 2 PH-HFpEF, NYHA Class II-IV symptoms, and qualifying hemodynamics, echocardiogram, and 6-MWD. Excludes patients with other WHO PH groups, specific cardiomyopathies, significant valve disease, pre-existing lung disease, or recent major surgery.
04
Endpoints
Primary
Six-Minute Walk Distance
Secondary
Kansas City Cardiomyopathy Questionnaire
Clinical Worsening Events
N-terminal pro b-type natriuretic peptide
New York Heart Association functional class
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