Understanding microcirculation and vascular function in adults after Fontan surgery
Microcirculation and Vascular Function After Fontan Surgery
This study looks at how well blood flows in adults who had Fontan surgery for heart problems, comparing them to healthy people and others who had different heart surgeries, to understand their long-term health issues better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT05683067 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the microcirculation and vascular function in adult survivors of Fontan surgery, a procedure performed on patients with congenital heart disease characterized by a single functioning ventricle. The study will compare the microcirculation of these patients with healthy individuals and those who have undergone surgery for other congenital heart conditions. By utilizing hand-held capillary microscopy and mobile vascular assessment tools, researchers hope to uncover the reasons behind the long-term complications faced by Fontan survivors, such as reduced heart function and organ issues. The findings could provide insights into the management and treatment of these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 16 to 50 who have undergone Fontan surgery or other congenital heart procedures.
Not a fit: Patients with significant comorbidities such as autoimmune diseases, arrhythmias, or peripheral vascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of complications in adult Fontan survivors, enhancing their quality of life.
How similar studies have performed: While there is limited research specifically on microcirculation in Fontan survivors, studies on vascular function in congenital heart disease have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 optimization of their circulation or for symptom management. Patients treated with anticoagulants and antiplatelets will be included in the study.
Where this trial is running
Leicester, Leicestershire
- Glenfield Hospital Leicester — Leicester, Leicestershire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.