Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05848102
Eligibility Criteria:
Inclusion Criteria:
1. Agree to get enrolled;
2. Age 18-90 years old, gender is not limited;
3. More than moderated FMR ( EROA by echocardiography ≥0.2cm2) , and LVEF more than 40%;
4. The structure of mitral valve leaflets and chordae is normal;
5. GDMT for FMR has been taken orally for more than 2 weeks, and the dose has not been adjusted for more than 2 weeks (If there is no contraindication, the drugs includes β blockers, the renin-angiotensin system inhibitors \[Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers/angiotensin receptor neprilysin inhibitor\], aldosterone receptor antagonists), and for the last 2 weeks no intravenous drug for heart failure were used.
Exclusion Criteria:
1. Have indication for dapagliflozin;
2. Angioedema, or allergic to dapagliflozin;
3. Already taking Dapagliflozin or other SGLT2 inhibitors;
4. Primary mitral valve structural damage, such as rheumatic heart disease, mitral valve prolapse;
5. Non-dialysis patients with estimated glomerular filtration rate\<30ml/min/1.73m2;
6. Dialysis patients;
7. Acute myocardial infarction, acute myocarditis, or percutaneous transluminal coronary intervention, coronary artery bypass grafting and other vascular reconstruction operations have occurred within 3 months;
8. Those who plan to take vascular reconstruction, cardiac resynchronization therapy, percutaneous mitral valve repair, surgical valve repair or replacement within 3 months after enrollment;
9. Complications of obvious aortic valve disease (more than moderate stenosis or more than moderate regurgitation);
10. Thyroid function combined with hyperthyroidism has not returned to normal;
11. Pregnant and lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05848102
Study Brief:
Protocol Section:
NCT05848102