Ventricular and Pulmonary Vascular Reserve After the Fontan Operation
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 2/28/2019 |
| Start Date: | August 30, 2018 |
| End Date: | March 2023 |
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. 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.
Aim #2: 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.
Aim #3: 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, and 24 months 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.
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.
Aim #2: 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.
Aim #3: 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, and 24 months 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.
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, and 24 months 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.
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, and 24 months 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.
Inclusion Criteria:
- Fontan Palliation
- Age ≥18 years
Exclusion Criteria:
-No clinical indication for cardiac catheterization
We found this trial at
1
site
Rochester, Minnesota 55905
Principal Investigator: Alexander Egbe, MD
Phone: 507-284-2520
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