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Microcirculation and Vascular Function After Fontan Surgery

NCT05683067 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2023-07-20

No results posted yet for this study

Summary

Fontan Surgery is done for children with only one working lower chamber of the heart called the 'Single Ventricle'. This surgery involves making connections between the two big veins that drain oxygen deficient blood to the heart and the lung artery directly. Fontan patients may develop long-term complications such as reduced heart function or oxygen levels, increased pressure in the veins, liver or kidney problems etc. The reasons for these complications are poorly understood. The small blood vessels in the body or 'microcirculation' are tiny (can be seen only by microscope) and they supply food and oxygen to the tissues. Very little is known about what happens to the microcirculation in adult Fontan survivors . In this study the investigator want to understand why these adult Fontan survivors develop complications by looking at their microcirculation and comparing them with healthy people and those who were operated for other congenital heart diseases. The study will be conducted in East Midlands Congenital Heart Centre, Glenfield Hospital.

Leicester.

Conditions

  • Congenital Heart Disease

Interventions

OTHER

Hand Held Capillary Microscopy

The investigator will visualize the blood vessel appearance, number, and size they have in their hands, feet, and under the tongue. This procedure is non-invasive and will not cause any pain.

OTHER

Mobile 'O' Graph

The aortic stiffness will be measured non-invasively using a special blood pressure monitor called Mobile 'O' Graph, which is about size of a pocket diary. 24 hour blood pressure monitoring is optional.

OTHER

quality of life using questionnaires

The investigator will evaluate the quality of life using questionnaires such as EQ-5D-5L questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-12
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683067 on ClinicalTrials.gov