NCT03853837

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

3.4 years

First QC Date

August 9, 2018

Last Update Submit

October 4, 2022

Conditions

Heart FailureCongenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Fontan Associated Liver Disease

    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;

    5 year

Secondary Outcomes (1)

  • Mortality

    5 years

Study Arms (2)

Prospective Fontan patients

Fontan patients to be enrolled and complete study tests/procedures

Diagnostic Test: rest-exercise echocardiography

Retrospective Fontan patients

Fontan patients to be retrospectively reviewed and used as control subjects

Interventions

rest-exercise echocardiographyDIAGNOSTIC_TEST

an echocardiogram performed during rest and exercise

Prospective Fontan patients

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fontan palliation

You may qualify if:

  • Fontan Palliation
  • Age ≥18 years

You may not qualify if:

  • No clinical indication for cardiac catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Heart FailureHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexander Egbe, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2018

First Posted

February 26, 2019

Study Start

August 30, 2018

Primary Completion

January 4, 2022

Study Completion

July 21, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Locations

US(1)