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Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05773300
Collaborator
National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
75
Enrollment
1
Location
46.8
Anticipated Duration (Months)
1.6
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 [Patient Registry]
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry
    Actual Study Start Date :
    Jan 6, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Peak Oxygen Uptake [6 Months]

      Peak Oxygen Uptake (L/min) : 1.7 ± 0.1

    2. Peak Right Ventricular - Pulmonary Coupling [6 Months]

      Peak Right Ventricular - Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI ≤ 30.

    • No current cardiac medications.

    • Systolic BP ≤ 140 mmHg.

    • Diastolic BP ≤ 90 mmHg.

    • Capacity to consent.

    Exclusion Criteria:

    • To be assessed via EMR screening.

    • Patient confirmation during screening visit.

    • Screening tests as applicable.

    • History of cardiovascular disease. eGFR < 30.

    • Current orthopedic limitations.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Mayo Clinic
    • National Institutes of Health (NIH)
    • 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:
    NCT05773300
    Other Study ID Numbers:
    • 21-011938
    • R01HL158517
    First Posted:
    Mar 17, 2023
    Last Update Posted:
    Mar 17, 2023
    Last Verified:
    Mar 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 Mar 17, 2023