Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy
NCT ID: NCT06278727
Last Updated: 2024-02-26
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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RECRUITING
270 participants
OBSERVATIONAL
2024-01-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Regression group
Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months.
angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor
Guideline-directed Medical Therapy (GDMT) includes those 4 drugs, and only taking at least 3 drugs could be recognized as GDMT.
The development of the prediction model
The prediction model of FMR regression would be developed to recognize patients whose FMR would regress due to GDMT, and consequently help determine the treatment.
No-reaction group
No-reaction group contains the patients whose FMR has no regression by every clinical visit.
angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor
Guideline-directed Medical Therapy (GDMT) includes those 4 drugs, and only taking at least 3 drugs could be recognized as GDMT.
Interventions
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angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor
Guideline-directed Medical Therapy (GDMT) includes those 4 drugs, and only taking at least 3 drugs could be recognized as GDMT.
The development of the prediction model
The prediction model of FMR regression would be developed to recognize patients whose FMR would regress due to GDMT, and consequently help determine the treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥2+ FMR
* Receiving GDMT
Exclusion Criteria
* myocardial infarction, percutaneous coronary intervention, coronary bypass grafting surgery, cardiac resynchronization therapy, or stroke within three months prior to this study
* ≥2+ aortic stenosis or regurgitation
* previous surgical mitral valve repair or replacement
* restrictive cardiomyopthy, hypertrophic cardiomyopathy, or constrictive pericarditis
* severe heart failure (NYHA class IV) or left ventricular ejection fraction \< 20%
* symptomatic hypotension affecting GDMT prescription
* severe hepatic or renal insufficiency
* life expectancy \< 12 months
* Pregnancy
18 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Locations
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Sun-Yatsen Memorial Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Maohuan Lin
Role: primary
Other Identifiers
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SYSKY-2023-1173-01
Identifier Type: -
Identifier Source: org_study_id
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