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

NCT06278727 | Recruiting

• 1 other identifier: SYSKY-2023-1173-01
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation; Heart Failure

Outcome Measures

Primary Outcomes (1)

• FMR regression rate

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

  3 months

Secondary Outcomes (2)

• FMR regression rate

  6 months

• composite endpoint

  one year

Study Arms (2)

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; Other: The development of the prediction model

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

Interventions

angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor DRUG

Guideline-directed Medical Therapy (GDMT) includes those 4 drugs, and only taking at least 3 drugs could be recognized as GDMT.

Also known as: beta-blockers, mineralcorticoid recept antagonist, sodium-glucose linked transporter-2 inhibitor

No-reaction group; Regression group

The development of the prediction model OTHER

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.

Regression group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sun-Yatsen Memorial Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Failure

Interventions

Angiotensin-Converting Enzyme Inhibitors; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs

Central Study Contacts

Maohuan Lin

CONTACT

+86 13580575861; Maohuan_Lin@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 26, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CN (1)