Registry for Mayo Clinic Adult Congenital Heart Disease Control Population
March 10, 2026 updated by: Alexander C. Egbe, Mayo Clinic
Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Oxygen Uptake
Time Frame: 6 Months
|
Peak Oxygen Uptake (L/min) : 1.7 ± 0.1
|
6 Months
|
|
Peak Right Ventricular - Pulmonary Coupling
Time Frame: 6 Months
|
Peak Right Ventricular - Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander Egbe, MBBS, MPH, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 6, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 10, 2023
First Submitted That Met QC Criteria
March 10, 2023
First Posted (Actual)
March 17, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-011938
- R01HL158517 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.