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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06278727
• Other study ID #: SYSKY-2023-1173-01
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Maohuan Lin
• Phone: +86 13580575861
• Email: Maohuan_Lin[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Drug:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
China	Sun-Yatsen Memorial Hospital	Canton	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMR regression rate	the rate of FMR regression by at least 1 grade by 3 months	3 months
Secondary	FMR regression rate	the rate of FMR regression by at least 1 grade by 6 months	6 months
Secondary	composite endpoint	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.	one year