Single-ventricleNCT04017494
Validation of Cardiac Magnetic Resonance Sequences in Patients With Single Ventricles
An observational study of Single-ventricle, run by Barbara Burkhardt at 1 site in Switzerland.
Trial summary
Single ventricle defects make up the severe end of the congenital heart disease spectrum. The Fontan operation leads to a complete redirection of systemic venous blood outside of the heart and directly into the lungs. Patients with single ventricles suffer from multiple complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Single-ventricle
- What is being tested?
- Cardiac Magnetic Resonance Imaging, Blood draw for hematocrit and heart failure biomarkers and Cardiopulmonary exercise test
- Type of treatment
- Injection or infusion
- How many people
- 63 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2019to 31 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with single ventricle physiology
Who may be able to join
- Patients of any age with functionally single ventricle (patients under age 8 who need anesthesia for CMR will not be actively recruited. They may be approached to participate only if the anesthesia and CMR examination have been planned independently for clinical purposes)
- Written informed consent
Who cannot join
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, inability to give assent or consent, etc. of the participant and/or his/her parents or legal caregivers
- MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging (patient and guardians fill out a questionnaire).
- Pregnancy
- Participation in another study is not an exclusion criterion, e.g. in a therapeutic trial.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zürich, Switzerland
Zurich, Canton of Zurich, 8032
About this study
Single ventricle defects make up the severe end of the congenital heart disease spectrum. The Fontan operation leads to a complete redirection of systemic venous blood outside of the heart and directly into the lungs. Patients with single ventricles suffer from multiple complications. Their survival has improved over the past decades, but is still severely compromised compared to the general population.
Their evaluation includes echocardiography and functional status by history and/or exercise testing. In longer intervals or if echocardiography does not allow visualization of all cardiovascular structures, cardiac magnetic resonance (CMR) is employed. Many patients also undergo more invasive cardiac catheterization.
Read more
In single ventricle patients, cardiac imaging has to address the questions of the patency of the Fontan pathways, i.e. all systemic veins, the Fontan conduit, and the pulmonary arteries, and of the function of the single ventricle (including myocardial function and valve function).
By using conventional imaging methods in Fontan patients, Ghelani et al. identified a CMR-based ventricular end-diastolic volume of > 125 ml/m2 and an echocardiographic global circumferential strain (GCS) value of higher than -17% to be strong predictors for a combined adverse outcome of death or heart transplantation. While interobserver reproducibility of single ventricle ejection fraction is similarly high by echocardiography, CMR is better in reliably measuring ventricular mass and diastolic volume and can provide additional information by MR feature tracking (strain), T1 mapping, and 4D flow measurements. Several substances that can be measured in the peripheral blood are being increasingly investigated as biomarkers of heart failure.
In conclusion, several advanced CMR sequences and new biomarkers have a potential role in the assessment and risk stratification of single ventricle patients. Every single published study has elucidated a particular use and aspect of these parameters, but broader correlations and prognostic values are still unclear.
The investigators hypothesize that myocardial strain (by feature tracking), myocardial fibrosis (by T1 mapping), and intracardiac flow disturbances (by 4D flow) along with biomarkers are diagnostic for single ventricle dysfunction and correlate with known prognostic factors.
This is a single center, prospective, observational cohort study. There will be no randomisation or blinding. Study setting: outpatients, cardiology clinic and radiology department, academic hospital. Every patient will be examined twice with a one-year interval (MR will only be repeated if clinically indicated).
- Conditions
- Single-ventricle
- Being tested
- Cardiac Magnetic Resonance Imaging, Blood draw for hematocrit and heart failure biomarkers, Cardiopulmonary exercise test, Exhalomics, Quality of life questionnaire
- Keywords
- Fontan, Congenital heart defects, Non-invasive cardiac imaging, Biomarkers
- Medical subject headings
- Univentricular Heart, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingDiagnostic test
Cardiac Magnetic Resonance Imaging (non-invasive, with i.v. application of contrast), awake or (if clinically indicated) in general anesthesia
Blood draw for hematocrit and heart failure biomarkersDiagnostic test
Approximately 10 ml of blood will be drawn before administration of contrast medium.
Cardiopulmonary exercise testDiagnostic test
In patients 8 years of age or older: on a cycle ergometer with breath-by-breath analysis, continuous ECG and SpO2 monitoring during exercise, after a baseline spirometry and bodyplethysmography
ExhalomicsDiagnostic test
Measurement of exhaled molecules by mass spectrometry; patients breathe into a mouthpiece for 15 seconds 6 times (total time requirement: about 5 minutes)
Quality of life questionnaireDiagnostic test
Questionnaire to be filled out by the Patient regarding quality of life perception
| Study group | Role | What they receive |
|---|---|---|
| Single ventricle | Patients with single ventricle lesions Receives: Diagnostic Test: Cardiac Magnetic Resonance Imaging; Diagnostic Test: Blood draw for hematocrit and heart failure biomarkers; Diagnostic Test: Cardiopulmonary exercise test; Diagnostic Test: Exhalomics; Diagnostic Test: Quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strain correlation with ventricular volume
Strain correlation with ventricular volume measured by magnetic resonance imaging
Measured: 1 year
Strain correlation with clinical parameters
Strain correlation with clinical parameters such as presence of arrhythmias on Holter-EKG, maximal oxygen consumption on cardio-pulmonary exercise testing (ml/(kg*min))
Measured: 1 year
Secondary outcomes (3)
T1 values compared to previously established normal cohort
T1 values compared to previously established normal cohort
Measured: 1 year
Blood and exhaled biomarkers of heart failure correlation with T1 mapping
Blood and exhaled biomarkers of heart failure correlation with T1 mapping
Measured: 1 year
Intraventricular blood flow correlation with cardiac function
Intraventricular blood flow correlation with cardiac ejection fraction measured by magnetic resonance imaging
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-ventricleStudies 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Burkhardt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Barbara Burkhardt, University Children's Hospital, Zurich
- Investigators
- Barbara EU Burkhardt, MD, Principal investigator, University of Zurich Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017494
- Sponsor's protocol ID
- SV-CMR
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cardiac Magnetic Resonance Sequences in Patients With Single Ventricles
- ClinicalTrials.gov ID
- NCT04017494
- Acronym / sponsor ID
- SV-CMR
- Conditions
- Single-ventricle
- Keywords
- Fontan, Congenital heart defects, Non-invasive cardiac imaging, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Barbara BurkhardtUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 12 Jul 2019 (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.
Single ventricle defects make up the severe end of the congenital heart disease spectrum. The Fontan operation leads to a complete redirection of systemic venous blood outside of the heart and directly into the lungs. Patients with single ventricles suffer from multiple complications. Their survival has improved over the past decades, but is still severely compromised compared to the general population.
Their evaluation includes echocardiography and functional status by history and/or exercise testing. In longer intervals or if echocardiography does not allow visualization of all cardiovascular structures, cardiac magnetic resonance (CMR) is employed. Many patients also undergo more invasive cardiac catheterization.
In single ventricle patients, cardiac imaging has to address the questions of the patency of the Fontan pathways, i.e. all systemic veins, the Fontan conduit, and the pulmonary arteries, and of the function of the single ventricle (including myocardial function and valve function).
By using conventional imaging methods in Fontan patients, Ghelani et al. identified a CMR-based ventricular end-diastolic volume of > 125 ml/m2 and an echocardiographic global circumferential strain (GCS) value of higher than -17% to be strong predictors for a combined adverse outcome of death or heart transplantation. While interobserver reproducibility of single ventricle ejection fraction is similarly high by echocardiography, CMR is better in reliably measuring ventricular mass and diastolic volume and can provide additional information by MR feature tracking (strain), T1 mapping, and 4D flow measurements. Several substances that can be measured in the peripheral blood are being increasingly investigated as biomarkers of heart failure.
In conclusion, several advanced CMR sequences and new biomarkers have a potential role in the assessment and risk stratification of single ventricle patients. Every single published study has elucidated a particular use and aspect of these parameters, but broader correlations and prognostic values are still unclear.
The investigators hypothesize that myocardial strain (by feature tracking), myocardial fibrosis (by T1 mapping), and intracardiac flow disturbances (by 4D flow) along with biomarkers are diagnostic for single ventricle dysfunction and correlate with known prognostic factors.
This is a single center, prospective, observational cohort study. There will be no randomisation or blinding. Study setting: outpatients, cardiology clinic and radiology department, academic hospital. Every patient will be examined twice with a one-year interval (MR will only be repeated if clinically indicated).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single ventricle | – | Diagnostic Test: Cardiac Magnetic Resonance Imaging, Diagnostic Test: Blood draw for hematocrit and heart failure biomarkers, Diagnostic Test: Cardiopulmonary exercise test, Diagnostic Test: Exhalomics, Diagnostic Test: Quality of life questionnairePatients with single ventricle lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with single ventricle physiology
Key inclusion criteria (2 listed)
- Patients of any age with functionally single ventricle (patients under age 8 who need anesthesia for CMR will not be actively recruited. They may be approached to participate only if the anesthesia and CMR examination have been planned independently for clinical purposes)
- Written informed consent
Key exclusion criteria (4 listed)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, inability to give assent or consent, etc. of the participant and/or his/her parents or legal caregivers
- MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging (patient and guardians fill out a questionnaire).
- Pregnancy
- Participation in another study is not an exclusion criterion, e.g. in a therapeutic trial.
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 |
|---|---|---|
| Cardiac Magnetic Resonance ImagingCardiac Magnetic Resonance Imaging (non-invasive, with i.v. application of contrast), awake or (if clinically indicated) in general anesthesia | Diagnostic test | Single ventricle |
| Blood draw for hematocrit and heart failure biomarkersApproximately 10 ml of blood will be drawn before administration of contrast medium. | Diagnostic test | Single ventricle |
| Cardiopulmonary exercise testIn patients 8 years of age or older: on a cycle ergometer with breath-by-breath analysis, continuous ECG and SpO2 monitoring during exercise, after a baseline spirometry and bodyplethysmography | Diagnostic test | Single ventricle |
| ExhalomicsMeasurement of exhaled molecules by mass spectrometry; patients breathe into a mouthpiece for 15 seconds 6 times (total time requirement: about 5 minutes) | Diagnostic test | Single ventricle |
| Quality of life questionnaireQuestionnaire to be filled out by the Patient regarding quality of life perception | Diagnostic test | Single ventricle |
Primary outcome
Strain correlation with ventricular volume
Time frame: 1 year
Strain correlation with ventricular volume measured by magnetic resonance imaging
Strain correlation with clinical parameters
Time frame: 1 year
Strain correlation with clinical parameters such as presence of arrhythmias on Holter-EKG, maximal oxygen consumption on cardio-pulmonary exercise testing (ml/(kg*min))
3 secondary outcomes
T1 values compared to previously established normal cohort
Time frame: 1 year
Blood and exhaled biomarkers of heart failure correlation with T1 mapping
Time frame: 1 year
Intraventricular blood flow correlation with cardiac function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Barbara EU Burkhardt, MD principal investigator
University of Zurich Children's Hospital
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 Single-ventricle, run by Barbara Burkhardt at 1 site in Switzerland.
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 2 inclusion and 4 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 12 Jul 2019. 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 Switzerland. 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?
Contact Barbara EU Burkhardt, MD (+41442667111, barbara.burkhardt@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strain correlation with ventricular volume (time frame: 1 year). The study lists 2 primary outcomes in all. 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 12 Jul 2019.