3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation

NCT ID: NCT04442828

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-17

Study Completion Date

2025-04-30

Brief Summary

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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

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Conditions

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Mitral Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary mitral regurgitation

Patients with mitral regurgitation due to mitral valve disease

Use of 3D echocardiography in patient follow-up

Intervention Type DIAGNOSTIC_TEST

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

Use of 3D echocardiography in patient follow-up

Intervention Type DIAGNOSTIC_TEST

Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Dana Cramariuc, MD PhD

Role: CONTACT

+4755976755

Facility Contacts

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Dana Cramariuc, MD PhD

Role: primary

+4755970534

References

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Berg-Hansen CE, Sindre RB, Grymyr LMD, Rogge B, Valeur AE, Urheim S, Hung J, Cramariuc D. Sex differences in left atrial volumes, mechanics, and stiffness in primary mitral regurgitation-a combined 2D and 3D echocardiographic study. Eur Heart J Cardiovasc Imaging. 2024 Jul 31;25(8):1118-1126. doi: 10.1093/ehjci/jeae072.

Reference Type DERIVED
PMID: 38469654 (View on PubMed)

Other Identifiers

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106848

Identifier Type: -

Identifier Source: org_study_id

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