NCT05773300

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2022Dec 2026

Study Start

First participant enrolled

January 6, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

March 10, 2023

Last Update Submit

March 10, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • BMI ≤ 30.
  • No current cardiac medications.
  • Systolic BP ≤ 140 mmHg.
  • Diastolic BP ≤ 90 mmHg.
  • Capacity to consent.

You may not qualify if:

  • To be assessed via EMR screening.
  • Patient confirmation during screening visit.
  • Screening tests as applicable.
  • History of cardiovascular disease. eGFR \< 30.
  • Current orthopedic limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2x1ml Whole Blood, 4x1mL plasma

Study Officials

  • Alexander Egbe, MBBS, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 17, 2023

Study Start

January 6, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)