Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection Fraction in Patients With CTD
NCT ID: NCT04197050
Last Updated: 2020-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2020-02-20
2022-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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Meng Jiang, MD
Role: STUDY_CHAIR
RenJi Hospital, School of Medicine, Shanghai Jiantong University
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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Other Identifiers
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2019-11-01R
Identifier Type: -
Identifier Source: org_study_id
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