Back to resultsStaging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
Primary Purpose
Tricuspid Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Magnetic Resonance
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Moderate or more tricuspid regurgitation
Exclusion Criteria:
- Prior tricuspid valve prosthesis
- Pacemaker/defibrillator that would impede MRI imaging
- Planned tricuspid valve surgery
- Primary liver pathology
Sites / Locations
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Moderate or severe tricuspid regurgitation
Arm 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.
Outcomes
Primary Outcome Measures
Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging
Incidence of severity of TR by CMR as compared with current gold standard (TTE)
Secondary Outcome Measures
Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography
Correlation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05006443
Brief Title
Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
Official Title
Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderate or severe tricuspid regurgitation
Arm Type
Other
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Magnetic Resonance
Other Intervention Name(s)
Cardiac MRI
Intervention Description
a non-invasive assessment to determine severity of tricuspid regurgitation
Primary Outcome Measure Information:
Title
Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging
Description
Incidence of severity of TR by CMR as compared with current gold standard (TTE)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography
Description
Correlation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate or more tricuspid regurgitation
Exclusion Criteria:
Prior tricuspid valve prosthesis
Pacemaker/defibrillator that would impede MRI imaging
Planned tricuspid valve surgery
Primary liver pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad Alkhouli
Phone
507-255-5846
Email
alkhouli.mohamad@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Alkhouli, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Alkhouli, MD
Phone
507-255-5846
Email
mohamad.alkhouli@mayo.edu
First Name & Middle Initial & Last Name & Degree
Mohamad Alkhouli, MD
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques
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