Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the study of patients with adult congenital heart disease (ACHD) considering its ability to determine detailed anatomy and detect early cardiac dysfunction without the need for radiation exposure. Most of contemporary treatment recommendations are based on consensus opinions/documents and small studies from local, or national registries. Improved knowledge is needed in all these areas to facilitate clinical decisions regarding treatment, monitoring and follow-up.
This study seeks to answer if early detection of deterioration in cardiac function, venous pressure and microvascular dysfunction can identify patients before the symptoms progress and thus help to initiate early treatment. The hypothesis is that quantitative myocardial stress-perfusion maps improves the pathophysiological insight in patients with UVH.
The overall goal with this research proposal is to implement combined advanced CMR imaging for a comprehensive non-invasive mapping of functional cardiovascular behavior in patients with complex UVH disease. The outcome of this research may benefit this young adult patient population due to early detection of cardiac disease, less hospitalizations because of heart failure, and eventually decrease morbidity and mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who had undergone total cavo-pulmonary connection (TCPC) surgery resulting in Fontan circulation.
NYHA (New York Heart Assosiation) class I-II.
Understanding the study information (signed informed consent).
>18 years old.
Disqualifiers
Device therapy (pacemaker, ICD).
Failing Fontan (NYHA III-IV).
Kidney failure (GFR<30ml/h).
Arrythmia (atrial fibrillation).
Trial population
The project is planned as a prospective cohort study where approximately 30 patients with Fontan circulation will be included. The cohort is out-clinic patients at the tertiary adult congenital heart disease center at the Karolinska University Hospital in Stockholm, Sweden. The patients will be asked to participate in the study when they have a clinical visit at Karolinska by the treating physician or nurse. Inclusion and exclusion criteria are shown above. Additional data will be collected from the patient cohort; age, gender, underlying diagnoses, interventions, medication, symptoms, NYHA functional class, ECG, cardiac pulmonary exercise results, self-reported level of physical activity, pacemaker / implantable cardioverter defibrillator (ICD), and quality of life assessed by EuroQoL 5-dimensional questionnaire (EQ-5D).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cardiac magnetic resonance stress-perfusion
Diagnostic testIncluded patients will be examined at the Karolinska University Hospital in a 1.5T Siemens Sola magnetic resonance camera at rest and during adenosine stress with specific CMR sequences (adenosine stress-perfusion, myocardial velocities, and tissue characterization) for non-invasive determination of macro- and microvascular dysfunction, global myocardial function, pulmonary artery pressure and scarring of the myocardium. Adenosine or Regadenoson will be used as stress medication which is according to clinical routine. Adenosine will be infused over approximately 5 minutes (110-140 μg / kg/min), Regadenoson (5 ml) will be a 10-second injection (400 μg single dosage). Intravenous gadolinium-based contrast agents will be administered, Gadovist (1 mmol/ml, gadobuterol), 0.15 mmol/kg during stress and rest.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Univentricle heart, operated with TCPC (total cavo pulmonary connection)1 intervention
Trial outcomes
Primary outcomes
1
Detection of microvascular dysfunction in patients with UVH
This project aims to evaluate microvascular dysfunction using quantitative stress-perfusion CMR in patients with different morphological systemic chamber (left vs right).
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
To detect and compare tissue characterization.
Investigate whether positive findings in tissue characterization is higher in different systemic ventricles (left vs right) using T1 and T2-mapping, LGE (late gadolinium enhancement, myocardial scar).
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Venous pressure in TCPC
Calculate venous delta pressure (customized in-house software) in the cavo-pulmonary connection using CMR 4D-flow imaging.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator
Source ClinicalTrials.gov