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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05773300
Other study ID # 21-011938
Secondary ID R01HL158517
Status Recruiting
Phase
First received
Last updated
Start date January 6, 2022
Est. completion date December 2025

Study information

Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak Oxygen Uptake Peak Oxygen Uptake (L/min) : 1.7 ± 0.1 6 Months
Primary Peak Right Ventricular - Pulmonary Coupling Peak Right Ventricular - Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065 6 Months
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