A Study of Hemodynamic Cardiopulmonary Exercise for CHD

NCT ID: NCT06566196

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at rest versus exercise, to assess the correlation between invasive and noninvasive (Doppler-derived) rest-exercise hemodynamic indices and to compare the association between indices of disease severity and hemodynamic abnormalities identified at rest versus exercise.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients Undergoing Clinically indicated Cardiac Cath

Group Type EXPERIMENTAL

Cardiac Cath

Intervention Type PROCEDURE

Patient will undergo standard of care Cardiac Cath and in addition invasive CPET (Cardiopulmonary exercise testing) will be performed during the procedure.

Interventions

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Cardiac Cath

Patient will undergo standard of care Cardiac Cath and in addition invasive CPET (Cardiopulmonary exercise testing) will be performed during the procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Congenital Heart Disease Diagnosis
* Undergoing Clinically indicated Cardiac Cath

Exclusion Criteria

* Unable to consent
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Alexander C. Egbe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Egbe, M.B.B.S., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ACHD Research Program

Role: CONTACT

507-293-2565

Other Identifiers

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5R01HL160761-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-004619

Identifier Type: -

Identifier Source: org_study_id

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