Microcirculation and Vascular Function After Fontan Surgery (NCT05683067) | Clinical Trial Compass
UnknownNot Applicable
Microcirculation and Vascular Function After Fontan Surgery
United Kingdom75 participantsStarted 2023-05-12
Plain-language 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.
Who can participate
Age range
16 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 op…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.