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OpenTrials
Completed

NCT Number: NCT03853837

Ventricular and Pulmonary Vascular Reserve After the Fontan Operation

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.

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Key information

Conditions

Heart Failure Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fontan Palliation
  • Age ≥18 years

Exclusion criteria

-No clinical indication for cardiac catheterization

Treatment and study plan

rest-exercise echocardiography

Diagnostic Test

an echocardiogram performed during rest and exercise

Primary outcomes

  1. Fontan Associated Liver Disease

    Time frame: 5 year

    Fontan associated liver disease measured via magnetic resonance elastography to find liver stiffness measured in kiloPascals:

    <2.5kPa = Normal; 2.5 to 3.0 kPa = Normal or inflammation; 3.0 to 3.5 kPa = Stage 1-2 fibrosis; 3.5 to 4 kPa = Stage 2-3 fibrosis; 4 to 5 kPa = Stage 3-4 fibrosis; >5 kPa = Stage 4 fibrosis;

Secondary outcomes

  1. Mortality

    Time frame: 5 years

    Mortality

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2019
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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