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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Maohuan Lin; Phone Number: +86 13580575861; Email: Maohuan_Lin@163.com

Study Locations

• China
  • Guangdong
    • Canton, Guangdong, China
      • Recruiting
      • Sun-Yatsen Memorial Hospital
      • Contact: Maohuan Lin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Regression group; Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months.	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 Names: beta-blockers; mineralcorticoid recept antagonist; sodium-glucose linked transporter-2 inhibitor; 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.
No-reaction group; No-reaction group contains the patients whose FMR has no regression by every clinical visit.	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 Names: beta-blockers; mineralcorticoid recept antagonist; sodium-glucose linked transporter-2 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMR regression rate	the rate of FMR regression by at least 1 grade by 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMR regression rate	the rate of FMR regression by at least 1 grade by 6 months	6 months
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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Estimated): February 26, 2024

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Failure; Mitral Valve Insufficiency; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Serine Proteinase Inhibitors; Vasoconstrictor Agents; Enzyme Inhibitors; Angiotensin II; Giapreza; Angiotensinogen; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists
• Other Study ID Numbers: SYSKY-2023-1173-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No