NCT03853837

Ventricular and Pulmonary Vascular Reserve After the Fontan Operation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing. Aim #2: Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology. Aim #3: Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction.

Detailed description

Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing. Subjects with Fontan palliation will undergo cardiac catheterization during exercise. The investigators hypothesize that invasive hemodynamic assessment during supine exercise will enable identification of early stage pulmonary vascular disease and diastolic dysfunction that is not apparent from invasive studies performed at rest. Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology. Transthoracic echocardiography will be performed at rest and during exercise simultaneously with catheterization in the subjects participating in Aim #1 to determine correlations between invasive and noninvasive hemodynamics and identify noninvasive alternatives to assess functional reserve. Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction. Multi-organ function and patient reported outcomes will be evaluated at baseline, 12 months (optional), and 24 months (optional) in subjects participating in Aims #1 and #2. The investigators hypothesize that subjects with poorer ventricular-vascular reserve will display more clinical and end-organ deterioration in longitudinal follow up.

Conditions

• Heart Failure
• Congenital Heart Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	rest-exercise echocardiography	an echocardiogram performed during rest and exercise

Timeline

• Start date: 2018-08-30
• Primary completion: 2022-01-04
• Completion: 2022-07-21
• First posted: 2019-02-26
• Last updated: 2022-10-06

Locations

1 site across 1 country: United States