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Sacubitril/Valsartan in CTD Patients With RV-HFrEF
NCT04197050Phase 4
Key facts
- Status
- Unknown
- Start
- Feb 2020
- Primary completion
- Nov 2022
- Countries
- 1
- Sponsor
- Renji Hospital
- Modality
- Small Molecules
- Drugs
- sacubitril
- Conditions
- Connective tissue disease (CTD)Right ventricular dysfunction (RVD)heart failure (HF)
01
Overview
Phase 4, randomised trial of sacubitril in Connective tissue disease (CTD), Right ventricular dysfunction (RVD) and heart failure (HF) (2 arms), sponsored by Renji Hospital. Primary endpoints: Exercise tolerance at 6 months and Fibrosis Assessment at 6 months. Status: unknown.
02
Design
2 arms- Study design
- Randomized
sacubitril/valsartan group
sacubitril/valsartan + optimal pharmaceutical treatment
control group
valsartan + optimal pharmaceutical treatment
03
Who it enrols
Adults aged 18-75 with confirmed Connective Tissue Disease (CTD) and right ventricular ejection fraction (RVEF) <= 45%, on optimal pharmaceutical treatment for CTD for at least 3 months. Excludes patients with coronary artery disease, congenital heart disease, or eGFR < 30 mL/min/1.73m^2.
04
Endpoints
Primary
Exercise tolerance
Fibrosis Assessment
Secondary
Connective Tissue Disease activity
Cardiovascular Mortality Rate
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