HealthyNCT05773300
Registry for Mayo Clinic Adult Congenital Heart Disease Control Population
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.
Who may be able to join
- BMI ≤ 30.
- No current cardiac medications.
- Systolic BP ≤ 140 mmHg.
- Diastolic BP ≤ 90 mmHg.
- Capacity to consent.
Who cannot join
- To be assessed via EMR screening.
- Patient confirmation during screening visit.
- Screening tests as applicable.
- History of cardiovascular disease. eGFR < 30.
- Current orthopedic limitations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Uptake
Peak Oxygen Uptake (L/min) : 1.7 ± 0.1
Measured: 6 Months
Peak Right Ventricular - Pulmonary Coupling
Peak Right Ventricular - Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start6 Jan 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alexander C. Egbe, Mayo Clinic
- Investigators
- Alexander Egbe, MBBS, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773300
- Sponsor's protocol ID
- 21-011938
- Other IDs
- R01HL158517
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control Population for the Mayo Clinic Adult Congenital Heart Disease Registry
- ClinicalTrials.gov ID
- NCT05773300
- Acronym / sponsor ID
- 21-011938
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.
Key inclusion criteria (5 listed)
- BMI ≤ 30.
- No current cardiac medications.
- Systolic BP ≤ 140 mmHg.
- Diastolic BP ≤ 90 mmHg.
- Capacity to consent.
Key exclusion criteria (5 listed)
- To be assessed via EMR screening.
- Patient confirmation during screening visit.
- Screening tests as applicable.
- History of cardiovascular disease. eGFR < 30.
- Current orthopedic limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak Oxygen Uptake
Time frame: 6 Months
Peak Oxygen Uptake (L/min) : 1.7 ± 0.1
Peak Right Ventricular - Pulmonary Coupling
Time frame: 6 Months
Peak Right Ventricular - Pulmonary Coupling: (|%|/mmHg): 0.786 ± 0.065
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Egbe, MBBS, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Uptake (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.