NCT05849025

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress82%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

April 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
3.1 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

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

April 27, 2023

Last Update Submit

April 29, 2026

Conditions

HealthyCongenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Pulmonary vascular reserve

    The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)

    Baseline

Eligibility Criteria

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

Healthy individuals without cardiac conditions will be recruited from Mayo Clinic in Rochester, MN.

You may qualify if:

  • 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

You may not qualify if:

  • History of Cardiovascular disease that may affect the results of the testing performed.
  • Any Current orthopedic limitations
  • Currently taking any cardiac medication
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexander Egbe, MBBS, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ACHD Research Program

CONTACT

(507) 293-2565

Alexander Egbe, MBBS, MPH

CONTACT

(507) 284-2520Egbe.Alexander@mayo.edu

Study Design

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

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 8, 2023

Study Start

October 16, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)