HealthyNCT05849025
A Study of Invasive Hemodynamic for MACHD Registry
An observational study of Healthy and Congenital Heart Disease, 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 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Congenital Heart Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals without cardiac conditions will be recruited from Mayo Clinic in Rochester, MN.
Who may be able to join
- 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
Who cannot join
- History of Cardiovascular disease that may affect the results of the testing performed.
- Any Current orthopedic limitations
- Currently taking any cardiac medication
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ACHD Research Program contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
ACHD Research Program, (507) 293-2565
Alexander Egbe, MBBS, MPH, (507) 284-2520, Egbe.Alexander@mayo.edu
About this study
Official title: Invasive Hemodynamic Control Cohort for The Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry
This research study is being done to provide comparative data to the Mayo Clinic Adult Congenital Heart Disease Registry.
- Conditions
- Healthy, Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary vascular reserve
The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start16 Oct 2023
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT05849025
- Sponsor's protocol ID
- 23-001939
- Other IDs
- R01HL160761
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2023
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Hemodynamic Control Cohort for The Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry
- ClinicalTrials.gov ID
- NCT05849025
- Acronym / sponsor ID
- 23-001939
- Conditions
- Healthy, Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals without cardiac conditions will be recruited from Mayo Clinic in Rochester, MN.
Key inclusion criteria (6 listed)
- Capacity to Consent
- BMI </= 30
- Systolic BP </= 140mmHg
- Diastolic BP </= 90
- eGFR > 30 (within prior 3 months) to confirm kidney function
Key exclusion criteria (4 listed)
- History of Cardiovascular disease that may affect the results of the testing performed.
- Any Current orthopedic limitations
- Currently taking any cardiac medication
- Pregnancy
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
Pulmonary vascular reserve
Time frame: Baseline
The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)
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 5 May 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.
ACHD Research Program contact
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 and Congenital Heart Disease, 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 May 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?
Contact ACHD Research Program ((507) 293-2565), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary vascular reserve (time frame: Baseline). 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 5 May 2026.