3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation

Recruiting

• Conditions: Mitral Regurgitation
• Interventions: Diagnostic Test: Use of 3D echocardiography in patient follow-up

• Registration Number: NCT04442828
• Lead Sponsor: Haukeland University Hospital

Brief Summary

The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-17
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adult patients with primary or secondary mitral regurgitation (MR)
• MR of moderate or severe degree
• 3D echocardiographic examinations of >= good spatial and temporal resolution

Exclusion Criteria

• Co-existence of another valve disease of severe degree
• Inability to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary mitral regurgitation	Use of 3D echocardiography in patient follow-up	Patients with mitral regurgitation due to mitral valve disease
Secondary mitral regurgitation	Use of 3D echocardiography in patient follow-up	Patients with mitral regurgitation due to ventricular or atrial disease

Primary Outcome Measures

Name	Time	Method
Major cardiovascular event	24 months	Death, mitral valve intervention, heart failure hospitalization

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	24 months
All-cause death	24 months
Mitral valve intervention	24 months

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway