Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection Fraction in Patients With CTD

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Heart failure, one of the leading causes of connective tissue disease (CTD) mortality, has attracted increasing attention. Currently, no known study had focused on the effect of sacubitril/valsartan on right ventricular dysfunction and in the systemic disease induced heart disease. We aimed to observe the effect of sacubitril/valsartan on primary endpoints (6 minutes walking test and myocardial fibrosis) in CTD patients with right ventricular ejection fraction reduction (RV-HFrEF).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: LCZ 696; Valsartan

Criteria

Inclusion Criteria:

• Age between 18-75 years old.

• confirmed CTD（including systemic lupus erythematosus, myositis, polymyositis, systemic sclerosis, sarcoid, Sjögren's syndrome or mixed connective tissue disease）

• SLEDAI ≤ 6 in patients with SLE or ESR ≤ 30 in patients with SSc

• already have OPT for CTD at least 3 month

• RVEF ≤ 45%

• Providing written informed consent

Exclusion Criteria:

• Documented coronary artery disease or prior angiography for coronary artery disease (>50% stenosis).

• Patients with known congenital heart disease or other systemic diseases that might induce RVrEF.

• Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate < 30 ml/min/1.73 m2.