Registry for Mayo Clinic Adult Congenital Heart Disease C... | NCT05773300

Studies
Registry for Mayo Clinic Adult Congenital Heart Disease Control Population

NCT05773300

Sponsor

Mayo Clinic

Status

Active, not recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

66Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL158517	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 6, 2022Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Mar 10, 2023

First Submission Date that Met QC Criteria

Mar 10, 2023

First Posted Date

Mar 17, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexander C. Egbe, Principal Investigator, Mayo ClinicPrincipal Investigator

Lead Sponsor

Mayo ClinicOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

66Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Oxygen Uptake	Peak Oxygen Uptake (L/min) : 1.7 ± 0.1	6 Months
Peak Right Ventricular - Pulmonary Coupling	Peak Right Ventricular - Pulmonary Coupling: (\|%\|/mmHg): 0.786 ± 0.065	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects will be healthy individuals with no history of cardiovascular disease selected from Mayo Clinic in Rochester, Minnesota.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexander Egbe, MBBS, MPH	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Minnesota		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided