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

NCT04197050 | Unknown Phase 4 DMC

• 1 other identifier: 2019-11-01R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myocardial Injury; Connective Tissue Diseases

Keywords

Connective Tissue Diseases; sacubitril/valsartan; Cardiovascular Magnetic Resonance; Extracellular Volume; exercise tolerance

Outcome Measures

Primary Outcomes (3)

• Exercise tolerance

  6 minutes walking test

  change between 1 and 6 months after treatment

• Fibrosis Assessment

  LGE assessment

  change between 1 and 6 months after treatment

• Fibrosis Assessment

  ECV quantification

  change between 1 and 6 months after treatment

Secondary Outcomes (2)

• CTD activity

  change between 1 and 6 months after treatment

• Cardiovascular Mortality Rate

  change between 1 and 6 months after treatment

Study Arms (2)

sacubitril/valsartan group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

Sacubitril / Valsartan Oral Tablet DRUG

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.

Also known as: CMR examination

sacubitril/valsartan group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

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MeSH Terms

Conditions

Connective Tissue Diseases

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Meng Jiang, MD

  RenJi Hospital, School of Medicine, Shanghai Jiantong University

  STUDY CHAIR

Central Study Contacts

Meng Jiang, MD

CONTACT

+86 13788912766; jiangmeng0919@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 12, 2019
• Study Start: February 20, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: January 7, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)