Att Överleva Och Leva Som Vuxen Med Enkammarhjärta I Sverige

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Peder Sorensson, MD, Associate professor
peder.sorensson@ki.se
+46 731 400059
Backup
Ayse-Gul Ozturk, MD
ayse-gul.ozturk@ki.se
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 30
Treatments
Univentricle heart, operated with TCPC (total cavo pulmonary connection)
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska University Hospital
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov