NCT06735521Recruiting
Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation
Att Överleva Och Leva Som Vuxen Med Enkammarhjärta I Sverige
Source: ClinicalTrials.gov · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 16 Oct 2024
- Start date
- 15 Apr 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Karolinska Institutet
- Diseases
- Heart failure
- NCT number
- NCT06735521
What you commit to
- Study type: Observational
- Planned participants: 30
- From 15 Apr 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Device therapy (pacemaker, ICD).
Lab values
- Kidney failure (GFR\<30ml/h).
Other
- Failing Fontan (NYHA III-IV).
- Arrythmia (atrial fibrillation).
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.