Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

Patients with CTD frequently exhibit multi-organ pathophysiological and functional damage. Heart failure, one of the leading causes of CTD mortality, has attracted increasing attention. Mostly, patients with CTD present with nonspecific cardiac symptoms, normal ECG, and preserved left ventricular ejection fraction (LVEF) and therefore do not receive an early cardiac diagnosis and treatment. Pulmonary arterial hypertension (PAH), right ventricular (RV) dilatation and hypertrophy might become the first and the most frequent cardiac findings. Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitors, is a "superstar" which inhibits both neprilysin and renin-angiotensin aldosterone system that closely related to the heart failure mechanism. It has been strongly recommended as class I drug in treating the patient with chronic HFrEF from 2017 ACC/AHA/HFSA heart failure guideline for the ability of dramatically reduce the cardiovascular mortality rate.

Cardiovascular magnetic resonance (CMR) is able to depict myocardial characteristics from structure to tissue properties using cine and late gadolinium enhancement (LGE) sequences. Newly developed imaging studies to date include T1 mapping and T1-derived extracellular volume estimation. All the previous studies in CTD have been restricted to patients with advanced cardiac involvement.

Together with clinical assessment and multi-imaging tests, the aim of the present study is going to observe the effect of sacubitril/valsartan on primary endpoints (6 minutes walking test and myocardial fibrosis) in CTD patients with RV-HFrEF. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04197050
Study type	Interventional
Source	RenJi Hospital
Contact	Meng Jiang, MD
Phone	+86 13788912766
Email	jiangmeng0919@163.com
Status	Not yet recruiting
Phase	Phase 4
Start date	February 20, 2020
Completion date	November 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection Fraction in Patients With CTD — EARLY-MYO-CTD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms