Heart Failure, Mitral Regurgitation
Conditions
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.
Interventions
DRUGangiotensin-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.
OTHERThe 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.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FMR regression rate | 3 months | the rate of FMR regression by at least 1 grade by 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactMaohuan Lin
Outcome results
None listed