Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection Fraction in Patients With CTD (EARLY-MYO-CTD)
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|ClinicalTrials.gov Identifier: NCT04197050|
Recruitment Status : Not yet recruiting
First Posted : December 12, 2019
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Injury Connective Tissue Diseases||Drug: Sacubitril / Valsartan Oral Tablet||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Sacubitril/Valsartan on Right Ventricular Dysfunctioning Patients With Connective Tissue Disease|
|Estimated Study Start Date :||February 20, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Experimental: sacubitril/valsartan group
The diagnosis of CTD was made based on the clinical classification criteria. The patient was diagnosed by an echocardiography demonstration, when RVEF is suggested lower or equal to 45%, the patient will be considered a candidate after consent is signed. sacubitril/valsartan will be given.
Drug: Sacubitril / Valsartan Oral Tablet
After recruiting participants and collecting the baseline information, sacubitril/valsartan group will receive sacubitril/valsartan and optimal pharmaceutical treatment (OPT). The control group will receive valsartan and OPT. A CMR scan and a post-processed imaging procedure will later be carried on in order to detect the cardiac impairment.
Other Name: CMR examination
No Intervention: control group
The diagnosis of CTD was made based on the clinical classification criteria. The patient was diagnosed by an echocardiography demonstration, when RVEF is suggested lower or equal to 45%, the patient will be considered a candidate after consent is signed. Valsartan will be given.
- Exercise tolerance [ Time Frame: change between 1 and 6 months after treatment ]6 minutes walking test
- Fibrosis Assessment [ Time Frame: change between 1 and 6 months after treatment ]LGE assessment
- Fibrosis Assessment [ Time Frame: change between 1 and 6 months after treatment ]ECV quantification
- CTD activity [ Time Frame: change between 1 and 6 months after treatment ]antinuclear antibody
- Cardiovascular Mortality Rate [ Time Frame: change between 1 and 6 months after treatment ]all cause of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197050
|Contact: Meng Jiang, MD||+86 email@example.com|
|Shanghai, Shanghai, China, 200127|
|Study Chair:||Meng Jiang, MD||RenJi Hospital, School of Medicine, Shanghai Jiantong University|