3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation (3D-PRIME)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Diagnostic test: Use of 3D echocardiography in patient follow-up

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dana Cramariuc, MD PhD; Phone Number: +4755976755; Email: cdan@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Dana Cramariuc, MD PhD; Phone Number: +4755970534; Email: cdan@helse-bergen.no
    • Principal Investigator: Dana Cramariuc, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A cohort of patients with chronic mitral regurgitation referred for clinical and echocardiographic assessment at the Heart Valve Clinic at Haukeland University Hospital in Bergen, Norway.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary mitral regurgitation; Patients with mitral regurgitation due to mitral valve disease	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.
Secondary mitral regurgitation; Patients with mitral regurgitation due to ventricular or atrial disease	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular event	Death, mitral valve intervention, heart failure hospitalization	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause death	24 months
Cardiovascular death	24 months
Mitral valve intervention	24 months

Collaborators and Investigators

• Sponsor: Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 106848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No