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A Study of Invasive Hemodynamic for MACHD Registry

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05849025
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
50
Enrollment
1
Location
7
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Invasive Hemodynamic Control Cohort for The Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Pulmonary vascular reserve [Baseline]

      The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Capacity to Consent

    • BMI </= 30

    • Systolic BP </= 140mmHg

    • Diastolic BP </= 90

    • eGFR > 30 (within prior 3 months) to confirm kidney function

    • Able to undergo an MRI

    Exclusion Criteria:

    • History of Cardiovascular disease that may affect the results of the testing performed.

    • Any Current orthopedic limitations

    • Currently taking any cardiac medication

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Alexander Egbe, MBBS, MPH, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Alexander C. Egbe, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05849025
    Other Study ID Numbers:
    • 23-001939
    • R01HL160761
    First Posted:
    May 8, 2023
    Last Update Posted:
    May 8, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    No Results Posted as of May 8, 2023