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Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

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Mayo Clinic

Status

Completed

Conditions

Tricuspid Regurgitation

Treatments

Diagnostic Test: Cardiac Magnetic Resonance

Study type

Interventional

Funder types

Other

Identifiers

NCT05006443
21-003928

Details and patient eligibility

About

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).

Full 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.

Enrollment

75 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Moderate or more tricuspid regurgitation

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

75 participants in 1 patient group

Moderate or severe tricuspid regurgitation
Other group
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. 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.
Treatment:
Diagnostic Test: Cardiac Magnetic Resonance

Trial contacts and locations

1

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Central trial contact

Mohamad Alkhouli

Data sourced from clinicaltrials.gov

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