Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy

Recruiting

• Conditions: Heart Failure; Mitral Regurgitation
• Interventions: Drug: angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor; Other: The development of the prediction model

• Registration Number: NCT06278727
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Age>18 years old
• ≥2+ FMR
• Receiving GDMT

Exclusion Criteria

• degenerative mitral regurgitation
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regression group	angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor	Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months.
Regression group	The development of the prediction model	Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months.
No-reaction group	angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor	No-reaction group contains the patients whose FMR has no regression by every clinical visit.

Primary Outcome Measures

Name	Time	Method
FMR regression rate	3 months	the rate of FMR regression by at least 1 grade by 3 months

Secondary Outcome Measures

Name	Time	Method
FMR regression rate	6 months	the rate of FMR regression by at least 1 grade by 6 months
composite endpoint	one year	the composite endpoint includes all-cause mortality, worsening heart failure, and mitral intervention. The worsening heart failure includes heart failure hospitalization, NYHA cardiac function upgrades ≥1 grade, and acute heart failure needing diuretic or outpatient adjustment of prescription.

Trial Locations

Locations (1)

Sun-Yatsen Memorial Hospital; 🇨🇳 Canton, Guangdong, China