Predicting Mitral Regurgitation Improvement in Heart Failure Patients
Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy
This study is trying to see if current heart failure treatments can help improve mitral regurgitation in patients over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Canton, Guangdong) |
| Trial ID | NCT06278727 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a prediction model for the regression of functional mitral regurgitation in patients with heart failure who are receiving guideline-directed medical therapy. Patients diagnosed with at least moderate functional mitral regurgitation will be enrolled and followed clinically for a minimum of one year, with assessments at three, six, and twelve months. The study focuses on understanding how effective current treatments are in improving this condition over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with at least moderate functional mitral regurgitation who are receiving guideline-directed medical therapy.
Not a fit: Patients with degenerative mitral regurgitation or severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which heart failure patients are likely to benefit from current treatments for functional mitral regurgitation.
How similar studies have performed: Other studies have shown promise in developing predictive models for heart conditions, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Canton, Guangdong
- Sun-Yatsen Memorial Hospital — Canton, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Maohuan Lin
- Email: Maohuan_Lin@163.com
- Phone: +86 13580575861
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.