NCT05683067

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

December 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

May 12, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

December 12, 2022

Last Update Submit

July 18, 2023

Conditions

Congenital Heart Disease

Keywords

MicrocirculationFontan ProcedureVascular Function

Outcome Measures

Primary Outcomes (1)

  • In this study, the investigator want to look at the microcirculation using hand held capillary microscopy in the young and adult Fontan survivors compared to the age matched healthy people and the people operated for other congenital heart surgeries.

    The microcirculation will be studied in the skin of the hands, feet, and the mouth using handheld capillary microscopy

    One year

Secondary Outcomes (2)

  • The investigator want to measure the central blood pressure in the young and adult Fontan survivors compared to the age matched healthy people and the people operated for other congenital heart surgeries.

    One year

  • The investigator will measure the functional outcomes in young and adult Fontan survivors using questionnaires and study its relationship with microvascular assessments and vascular function.

    One Year

Study Arms (3)

Fontan Survivors

The investigator will include Fontan survivors between 16-50 years of age for the study.

Other: Hand Held Capillary MicroscopyOther: Mobile 'O' GraphOther: quality of life using questionnaires

People operated for congenital heart diseases

The investigator will include people operated for other types of congenital heart diseases such as tetralogy of Fallot, transposition of great arteries between 16 and 50 years of age

Other: Hand Held Capillary MicroscopyOther: Mobile 'O' GraphOther: quality of life using questionnaires

Healthy volunteers

The investigator will include healthy volunteers between 16 to 50 years of age for comparison purpose.

Other: Hand Held Capillary MicroscopyOther: Mobile 'O' GraphOther: quality of life using questionnaires

Interventions

Hand Held Capillary MicroscopyOTHER

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.

Fontan SurvivorsHealthy volunteersPeople operated for congenital heart diseases
Mobile 'O' GraphOTHER

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.

Fontan SurvivorsHealthy volunteersPeople operated for congenital heart diseases
quality of life using questionnairesOTHER

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)

Fontan SurvivorsHealthy volunteersPeople operated for congenital heart diseases

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

In this study, The investigator want to look at the blood vessels and test the vascular function in Fontan survivors, people operated for other congenital heart diseases, and healthy volunteers between 16 and 50 years of age

You may qualify if:

  • Patients operated for Fontan procedure or other congenital heart conditions
  • Patients ≥ 16 - 50 years of age
  • Participant/Parents/Guardian or legal representative willing and able to give Informed Consent for participation in the study
  • Able (in the Investigators opinion) and willing to comply with all study requirements

You may not qualify if:

  • Low blood pressure (90/60 mmHg with symptoms or on intravenous inotropes for maintenance of blood pressure)
  • Raynaud's disease
  • Autoimmune diseases
  • Down's syndrome as they have lower risk for vascular anomalies compared with the general population and may have different microvasculature
  • Treatment with sympathomimetic drugs
  • Atrial fibrillation or any other arrhythmia which might interfere with vascular function assessments.
  • Documented peripheral vascular disease
  • Skin disorders such as psoriasis or significant eczema
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Tremor or Inability to keep the hand still for 20 minutes.
  • Note: Patients treated with angiotensin converting enzyme inhibitors or angiotensin receptor inhibitors, beta blockers, vasodilators, diuretics and digoxin will be included in the study as the majority of Fontan survivors are taking one or more of these drugs for optimization of their circulation or for symptom management. Patients treated with anticoagulants and antiplatelets will be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glenfield Hospital Leicester

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

January 12, 2023

Study Start

May 12, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

GB(1)