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Recruiting NCT06566196

A Study of Hemodynamic Cardiopulmonary Exercise for CHD

No phase Interventional Congenital Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiac Cath.
Who it may be relevant to
Registry conditions: Congenital Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Invasive Hemodynamic Cardiopulmonary Exercise Testing for Assessment of Patients With Congenital Heart Disease (Cath CHD)

Overview

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.

Interventions

  • Procedure 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 measures

  • 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]

Eligibility criteria

Inclusion criteria

  • Congenital Heart Disease Diagnosis
  • Undergoing Clinically indicated Cardiac Cath

Exclusion criteria

  • Unable to consent
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT06566196 · 24-004619 · 5R01HL160761-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗