Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation
Launched by KAROLINSKA INSTITUTET · Dec 13, 2024
Trial Information
Current as of August 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a special heart imaging technique, called cardiac magnetic resonance (CMR), can help detect problems in patients with a rare heart condition known as univentricular heart (UVH). This condition affects how the heart pumps blood and can lead to serious issues like heart failure. The researchers want to see if they can spot early signs of heart problems and microvascular dysfunction—issues in the tiny blood vessels—before patients show any symptoms. By doing so, they hope to start treatment sooner, which could lead to better health and fewer hospital visits for these patients.
To participate in the study, individuals must be over 18 years old and have had a specific heart surgery called total cavo-pulmonary connection (TCPC) that results in Fontan circulation. They should also be in classes I or II of the New York Heart Association's classification, meaning they have mild symptoms. Unfortunately, those with more severe heart issues, certain heart devices, kidney failure, or who are pregnant cannot take part in the trial. Participants can expect to undergo advanced heart imaging procedures that are safe and do not involve radiation, helping to provide valuable information about their heart health. Overall, this study aims to improve care for young adults with this complex heart condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • Device therapy (pacemaker, ICD).
- • Failing Fontan (NYHA III-IV).
- • Kidney failure (GFR\<30ml/h).
- • Arrythmia (atrial fibrillation).
- • Pregnancy.
About Karolinska Institutet
Karolinska Institutet is a renowned medical university located in Sweden, recognized for its commitment to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the institution focuses on translating scientific discoveries into effective treatments and therapies, emphasizing patient-centered approaches. With a strong emphasis on collaboration and interdisciplinary research, Karolinska Institutet plays a pivotal role in addressing global health challenges and improving patient outcomes, leveraging its extensive network of experts and state-of-the-art facilities to drive clinical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported