Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Not Applicable

Active, not recruiting

• Conditions: Tricuspid Regurgitation
• Interventions: Diagnostic Test: Cardiac Magnetic Resonance

• Registration Number: NCT05006443
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

Detailed Description

40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Study Timeline

• Study First Submitted: 2021-07-31
• Study First Submitted QC: 2021-08-07
• Study First Posted: 2021-08-16
• Study Start: 2022-01-14
• Primary Completion: 2023-12-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-29
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Moderate or more tricuspid regurgitation

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Exclusion Criteria

1. Prior tricuspid valve prosthesis
2. Pacemaker/defibrillator that would impede MRI imaging
3. Planned tricuspid valve surgery
4. Primary liver pathology

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moderate or severe tricuspid regurgitation	Cardiac Magnetic Resonance	40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Primary Outcome Measures

Name	Time	Method
Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging	1 year	Incidence of severity of TR by CMR as compared with current gold standard (TTE)

Secondary Outcome Measures

Name	Time	Method
Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography	1 year	Correlation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States