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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regression group | Regression group contains the patients whose FMR regresses after taking GDMT for at least 3 months. |
| |
| No-reaction group | No-reaction group contains the patients whose FMR has no regression by every clinical visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| FMR regression rate | the rate of FMR regression by at least 1 grade by 3 months | 3 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maohuan Lin | Contact | +86 13580575861 | Maohuan_Lin@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun-Yatsen Memorial Hospital | Recruiting | Guangzhou | Guangdong | China |
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| 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. |
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| one year |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045505 | Physiological Effects of Drugs |
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