Status:
UNKNOWN
Gender Difference in NET Activation in Patients With Congenital Heart Disease and Heart Failure
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
National Research Agency, France
European Commission
Conditions:
Congenital Heart Disease
Heart Failure
Eligibility:
All Genders
18-45 years
Brief Summary
Neutrophil hyperactivation has detrimental effects on cardiac tissue after injuries, leading to fibrosis lesions and cardiac dysfunction. It is now well-established that women present with different c...
Detailed Description
100 patients (50 men and 50 women including 25% with a history of pregnancy) aged 18-45 years with moderate and severe CHD (Fallot, systemic RV, and single ventricle), where fibrosis has been identifi...
Eligibility Criteria
Inclusion
- Patients:
- Male or female aged 18 to 45; having one of the following 3 complex congenital heart disease:
- Congenital heart disease with a systemic right ventricle Congenital heart disease with a single ventricle palliated by Fontan's circulation Tetralogy of Fallot repaired - Patient benefiting from a social security scheme or having rights, or CMU; obtaining informed consent from the patient
- Healthy subjects:
- Age over 18 years old, matched by sex and age +/- 5 years; Normal ECG; with a prior clinical examination; benefiting from social security; obtaining informed consent from the patient
Exclusion
- Patients:
- patients with cyanosis defined as saturation ≤ 90% at rest; Usual MRI contraindications Possible confounding factors with increased NET formation unrelated to thrombosis, namely cancer, rheumatoid arthritis, lupus, antiphospholipid syndrome, history of pre-Eclampsia or hypertension; Contraindication to performing a stress test; Glomerular filtration rate \<30ml / min / 1.73m² of body surface area A physical or mental disability that does not allow for a stress test; Pregnant or lactating patient;Patient under legal protection
- \- Healthy subjects: Known or detectable history of a heart attack on the ECG; known or detectable primary or secondary cardiomyopathy on ECG; history of chest radiation therapy or chemotherapy;Possible confounding factors with increased NET formation unrelated to thrombosis, namely cancer, rheumatoid arthritis, lupus, antiphospholipid syndrome, history of pre-Eclampsia or hypertension Contraindication to performing a stress test;Glomerular filtration rate \<30ml / min;BMI\>30; Pregnant or lactating patient;Patient under legal protection
Key Trial Info
Start Date :
February 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 23 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05263843
Start Date
February 22 2022
End Date
February 23 2025
Last Update
January 9 2023
Active Locations (2)
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1
C01 - Hôpital Européen Georges Pompidou - Unité des cardiopathies congénitales de l'adulte
Paris, France, 75015
2
C02- Hôpital Européen Georges Pompidou - CIC
Paris, France, 75015