Recruiting

Hemodynamic Exercise

Sponsor:

Mayo Clinic

Code:

NCT06566196

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac Cath

Study Details

Brief summary:

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.

Conditions

Congenital Heart Disease

Study ID

NCT06566196

Start date

Feb 10, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Congenital Heart Disease Diagnosis
  • Undergoing Clinically indicated Cardiac Cath

Exclusion Criteria:

  • Unable to consent
  • Pregnancy

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Patients Undergoing Clinically indicated Cardiac Cath

Interventions

Cardiac Cath

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

Primary outcome measure

  • Change in left ventricular end-systolic elastance from rest to peak exercise [ Time Frame: Baseline ]
  • Change in Left ventricular cardiac output from rest to peak exercise [ Time Frame: Baseline ]
  • Change in systemic vascular resistance from rest to peak exercise [ Time Frame: Baseline ]
  • Change in right ventricular free-wall strain from rest to peak exercise [ Time Frame: Baseline ]
  • Change in right ventricular cardiac output from rest to peak exercise [ Time Frame: Baseline ]
  • Change in pulmonary vascular resistance from rest to peak exercise [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

ACHD Research Program

507-293-2565RSTACHDRESPRG@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

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

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-05.