Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Karolinska University Hospital
Coordinator of this site? Confirm its status
StockholmSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.