Congenital Heart DiseaseMICROFONNCT05683067
Microcirculation and Vascular Function After Fontan Surgery
An observational study of Congenital Heart Disease, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Hand Held Capillary Microscopy, Mobile 'O' Graph and quality of life using questionnaires
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital Leicester
Leicester, Leicestershire, LE3 9QP
Rajendra Raghuraman, MSc, 07838025043, rpr4@le.ac.uk
Frances Bu'Lock, MD, 0116 256 3904, frances.bulock@uhl-tr.nhs.uk
About this study
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.
Read the detailed description
In normal heart, there are two working lower chambers where one chamber pumps the blood to the lungs and other chamber pumps the blood to the body. However, some congenital heart conditions have only one working lower chamber of the heart called the 'Single Ventricle'. This condition is often associated with hole between the heart chambers with increased or decreased blood flow to the lungs. This can lead to mixing of blood in the heart with low oxygen levels in the body. The surgery for single ventricle is usually performed in stages starting from the infancy. Fontan surgery is the last stage where the two big veins that return the blood to the heart is connected to the lung artery directly. This surgery improves the oxygen levels in the blood and lessens the burden on the single ventricle. The blood is not pumped to the lungs by the heart but rather enters passively to the lungs through this new surgical connection. Some people operated for Fontan surgery have many short-term and long-term complications such as increased pressure in veins , poor heart function and low oxygen levels in the blood. In particular, the organs below the chest such as kidney, liver and gut are affected, and all of these predict poor outcomes. The reason for these complications are poorly understood.
The small blood vessels in the body or 'microcirculation' are very tiny and are less than 150 microns in diameter. These includes arterioles, capillaries, and venules. Very little is known about the microcirculation in adult Fontan survivors and its association with aortic stiffness, late complications, and quality of life. In this study, The investigators want to look at the blood vessels in adult Fontan survivors, people operated for other congenital heart diseases, and healthy volunteers using a special microscope called Hand Held Capillary Microscopy. The investigators will visualize their 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. 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. The investigator will also collect the information about the quality of life using questionnaires as few studies have shown that the quality of life is affected in adult Fontan survivors and it was associated with poor vascular function. Age matched healthy controls and adults survivors of other congenital heart surgeries will also undergo these tests for comparison purpose. This study will be conducted at East Midlands Congenital Heart Centre, Glenfield Hospital, Leicester.
- Conditions
- Congenital Heart Disease
- Being tested
- Hand Held Capillary Microscopy, Mobile 'O' Graph, quality of life using questionnaires
- Keywords
- Microcirculation, Fontan Procedure, Vascular Function
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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)
| Study group | Role | What they receive |
|---|---|---|
| Fontan Survivors | The investigator will include Fontan survivors between 16-50 years of age for the study. Receives: Other: Hand Held Capillary Microscopy; Other: Mobile 'O' Graph; Other: 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 Receives: Other: Hand Held Capillary Microscopy; Other: Mobile 'O' Graph; Other: quality of life using questionnaires | |
| Healthy volunteers | The investigator will include healthy volunteers between 16 to 50 years of age for comparison purpose. Receives: Other: Hand Held Capillary Microscopy; Other: Mobile 'O' Graph; Other: quality of life using questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
The central blood pressure, pulse wave velocity, and the augmentation index will be assessed by Mobile O Graph blood pressure monitor
Measured: 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.
The functional status will be assessed by Minnesota living with heart failure questionnaire
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start12 May 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683067
- Sponsor's protocol ID
- 0860
- Acronym
- MICROFON
- Status last verified
- Jul 2023
- First submitted
- 12 Dec 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This will be decided soon by the study team
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculation and Vascular Function After Fontan Surgery
- ClinicalTrials.gov ID
- NCT05683067
- Acronym / sponsor ID
- MICROFON / 0860
- Conditions
- Congenital Heart Disease
- Keywords
- Microcirculation, Fontan Procedure, Vascular Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In normal heart, there are two working lower chambers where one chamber pumps the blood to the lungs and other chamber pumps the blood to the body. However, some congenital heart conditions have only one working lower chamber of the heart called the 'Single Ventricle'. This condition is often associated with hole between the heart chambers with increased or decreased blood flow to the lungs. This can lead to mixing of blood in the heart with low oxygen levels in the body. The surgery for single ventricle is usually performed in stages starting from the infancy. Fontan surgery is the last stage where the two big veins that return the blood to the heart is connected to the lung artery directly. This surgery improves the oxygen levels in the blood and lessens the burden on the single ventricle. The blood is not pumped to the lungs by the heart but rather enters passively to the lungs through this new surgical connection. Some people operated for Fontan surgery have many short-term and long-term complications such as increased pressure in veins , poor heart function and low oxygen levels in the blood. In particular, the organs below the chest such as kidney, liver and gut are affected, and all of these predict poor outcomes. The reason for these complications are poorly understood.
The small blood vessels in the body or 'microcirculation' are very tiny and are less than 150 microns in diameter. These includes arterioles, capillaries, and venules. Very little is known about the microcirculation in adult Fontan survivors and its association with aortic stiffness, late complications, and quality of life. In this study, The investigators want to look at the blood vessels in adult Fontan survivors, people operated for other congenital heart diseases, and healthy volunteers using a special microscope called Hand Held Capillary Microscopy. The investigators will visualize their 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. 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. The investigator will also collect the information about the quality of life using questionnaires as few studies have shown that the quality of life is affected in adult Fontan survivors and it was associated with poor vascular function. Age matched healthy controls and adults survivors of other congenital heart surgeries will also undergo these tests for comparison purpose. This study will be conducted at East Midlands Congenital Heart Centre, Glenfield Hospital, Leicester.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fontan Survivors | – | Other: Hand Held Capillary Microscopy, Other: Mobile 'O' Graph, Other: quality of life using questionnairesThe investigator will include Fontan survivors between 16-50 years of age for the study. |
| People operated for congenital heart diseases | – | Other: Hand Held Capillary Microscopy, Other: Mobile 'O' Graph, Other: quality of life using questionnairesThe 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 |
| Healthy volunteers | – | Other: Hand Held Capillary Microscopy, Other: Mobile 'O' Graph, Other: quality of life using questionnairesThe investigator will include healthy volunteers between 16 to 50 years of age for comparison purpose. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Held Capillary MicroscopyThe 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 | Fontan Survivors, Healthy volunteers, People operated for congenital heart diseases |
| Mobile 'O' GraphThe 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 | Fontan Survivors, Healthy volunteers, People operated for congenital heart diseases |
| quality of life using questionnairesThe investigator will evaluate the quality of life using questionnaires such as EQ-5D-5L questionnaire and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) | Other | Fontan Survivors, Healthy volunteers, People operated for congenital heart diseases |
Primary outcome
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.
Time frame: One year
The microcirculation will be studied in the skin of the hands, feet, and the mouth using handheld capillary microscopy
2 secondary outcomes
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.
Time frame: 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.
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided. This will be decided soon by the study team
Related trials for Congenital Heart Disease
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
Not yet recruiting
Optimizing Care Transitions in CHD
Congenital Heart Disease (CHD), Mentorship
Active, not recruiting
Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
Serious Games, Transition-age Youth
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.