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NCT04442828 Clinical Trial

3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation

Mitral Regurgitation Clinical Trial

— 3D-PRIME  

Official title:
3D Echocardiography and Cardiovascular PRognosis In Mitral REgurgitation (3D-PRIME)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04442828
Other study ID # 106848
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 17, 2020
Est. completion date April 2025

Study information
Verified date September 2023
Source Haukeland University Hospital
Contact Dana Cramariuc, MD PhD
Phone +4755976755
Email cdan@helse-bergen.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date April 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Use of 3D echocardiography in patient follow-up
Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.

Locations
Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major cardiovascular event Death, mitral valve intervention, heart failure hospitalization 24 months
Secondary All-cause death 24 months
Secondary Cardiovascular death 24 months
Secondary Mitral valve intervention 24 months
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Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2