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REal-world obserVational study for invEstigAting the prevaLence and therapeutic options for Atrial Functional Mitral Regurgitation

REal-world obserVational study for invEstigAting the prevaLence and therapeutic options for Atrial Functional Mitral Regurgitation - REVEAL-AFMR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000046146
Enrollment
3000
Registered
2021-11-30
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial functional mitral regurgitation

Interventions

None listed

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1-Age 20 years or older at the time of enrollment 2-Preserved left ventricular function (left ventricular ejection fraction of 50% or more) 3-Left atrial enlargement (left atrial volume index of 38 mL/m2 or more for men and 41 mL/m2 or more for women. However, if the left atrial volume index is not shown, left atrial diameter of 40mm or more for men and 37mm or more for women) 4-Moderate or severe mitral regurgitation

Exclusion criteria

Exclusion criteria: 1.Patients with organic changes in mitral valve leaflets, i.e. rheumatic changes, prolapse, chordae rupture, infective endocarditis, radiation changes, severe calcification, congenital morphological abnormalities, etc. 2.MR due to mitral valve systolic anterior motion3.Patients with congenital heart disease except for those with a patent foramen ovale 4.Patients with mechanical circulatory assist device 5.Patients with history of mitral valve surgery or heart transplantation 6.Patients with acute heart failure 7.Others who are judged to be inappropriate as research subjects by the principal investigator

Design outcomes

Primary

MeasureTime frame
Combined endpoint of heart failure hospitalization and all-cause death

Secondary

MeasureTime frame
Cardiovascular death, non-cardiac death, stroke, major adverse cardiac events, sudden cardiac death, heart failure hospitalization, change in echocardiographic and clinical parameters

Countries

Japan

Contacts

Public ContactNobuyuki Kagiyama

Juntendo University Department of Cardiovascular Biology and Medicine

kgnb_27_hot@yahoo.co.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026