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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
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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).

Condition or disease Intervention/treatment Phase
Myocardial Injury Connective Tissue Diseases Drug: Sacubitril / Valsartan Oral Tablet Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Exercise tolerance [ Time Frame: change between 1 and 6 months after treatment ]
    6 minutes walking test

  2. Fibrosis Assessment [ Time Frame: change between 1 and 6 months after treatment ]
    LGE assessment

  3. Fibrosis Assessment [ Time Frame: change between 1 and 6 months after treatment ]
    ECV quantification


Secondary Outcome Measures :
  1. CTD activity [ Time Frame: change between 1 and 6 months after treatment ]
    antinuclear antibody

  2. Cardiovascular Mortality Rate [ Time Frame: change between 1 and 6 months after treatment ]
    all cause of death



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Meng Jiang, MD +86 13788912766 jiangmeng0919@163.com

Locations
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China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Meng Jiang, MD RenJi Hospital, School of Medicine, Shanghai Jiantong University
Publications:

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04197050    
Other Study ID Numbers: 2019-11-01R
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RenJi Hospital:
Connective Tissue Diseases
sacubitril/valsartan
Cardiovascular Magnetic Resonance
Extracellular Volume
exercise tolerance
Additional relevant MeSH terms:
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Connective Tissue Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action