Congenital Heart DiseaseFIBRONETxNCT05263843
Gender Difference in NET Activation in Patients With Congenital Heart Disease and Heart Failure
An observational study of Congenital Heart Disease and Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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 clinical symptoms in cardiovascular disease compared to men. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease, Heart Failure, Gender
- What is being tested?
- Biological markers of myocardial fibrosis
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Feb 2022to 23 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will therefore be represented by: * heart diseases at risk of heart failure with an equal proportion of men and women to be able to study the protective character of the female sex on the inflammatory process and the development of myocardial fibrosis. * healthy adult subjects.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
C01 - Hôpital Européen Georges Pompidou - Unité des cardiopathies congénitales de l'adulte
Paris, 75015
Magalie LADOUCEUR, MD, PHD, 0033156093043, magalie.ladouceur@aphp.fr
- Not yet recruiting
C02- Hôpital Européen Georges Pompidou - CIC
Paris, 75015
Jean-Sébastien HULOT, MD, PHD, 0033156092017, jean-sebastien.hulot@aphp.fr
About this study
Official title: Différences de Genre Dans l'Activation Des NET et Son Implication Dans la Formation de Fibrose Cardiaques Chez Les Patients Adultes Avec Une Cardiopathie congénitale Complexe FIBRONETx Gender
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 clinical symptoms in cardiovascular disease compared to men. A cardioprotective effect in women has been suggested in some studies including patients with congenital heart disease (CHD) and heart failure. Our hypothesis is that estrogen protects the hearts of female patients aged 18-45 with CHD. There is no information available as to the involvement of neutrophils in heart failure in females compared to male patients, and therefore this study will provide important information for both the CHD and neutrophil biology fields comparing NET activation in women and men with severe CHD.
Read the 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 identified as a risk factor for heart failure, will be included. A control group of 50 patients (25 men and 25 women) were matched on age and sex.
The main objective of the study is to study the difference in NET activation between men and women with complex congenital heart disease.
Secondary objectives are:
- To compare the NET activity between healthy subjects vs. patients at inclusion.
- To compare male vs. female NET activity in healthy subjects at inclusion.
- To study the existence of associations of NET with biomarkers of fibrosis (biological and imaging) at baseline in men and women with complex congenital heart disease.
- To study the protective value of pregnancy on inflammatory mechanisms and the formation of fibrosis involved in impaired ventricular function and heart failure in these patients.
The enrolled patients will have blood samples collected for analysis of PAD4/NETs biomarkers, and fibrosis markers. NET/fibrosis markers will be correlated with clinical/laboratory parameters, notably NET/PAD4 levels with markers of fibrosis such as collagen biomarkers, ECG, echocardiographic, and cardiac magnetic resonance imaging biomarkers.
- Conditions
- Congenital Heart Disease, Heart Failure, Gender
- Being tested
- Biological markers of myocardial fibrosis
- Keywords
- Congenital heart disease, Heart failure, Gender, Fibrosis, Inflammation
- Medical subject headings
- Heart Defects, Congenital, Heart Failure, Coitus, Fibrosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological markers of myocardial fibrosisDiagnostic test
Blood sample for measurements of NET activation and collagen biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with a complex congenital heart disease Receives: Diagnostic Test: Biological markers of myocardial fibrosis | |
| controls | healthy subjects Receives: Diagnostic Test: Biological markers of myocardial fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
NET activation levels and PAD4 Levels
Measurements of MPO-DNA, citrullinated histone, Elastase, Calprotectine, MMP9, NGAL, and MPO, IL-8
Measured: baseline
Secondary outcomes (6)
The association of NET / PAD4 biomarker levels will be analyzed to NYHA functional class.
The association between NYHA functional class (I, II, III and IV) and the following measurements will be analyzed:
- MPO-DNA (UA/mL)
- Citrullinated histone (optic density unit)
- Elastase (pg/mL)
- Calprotectine (pg/mL)
- MMP9 (pg/mL)
- NGAL (pg/mL)
- MPO (UA/mL)
- IL-8 (pg/ml)
Measured: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to QRS width and late potentials.
The association between each ECG parameters: QRS width (ms) and late potentials (present or absent) and the following measurements will be analyzed:
- MPO-DNA (UA/mL)
- Citrullinated histone (optic density unit)
- Elastase (pg/mL)
- Calprotectine (pg/mL)
- MMP9 (pg/mL)
- NGAL (pg/mL)
- MPO (UA/mL)
- IL-8 (pg/ml)
Measured: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to ventricular function, ventricular longitudinal strain, diastolic parameters, presence of valvular disease, change in systemic ventricular filling profile after exercise
The association between each echographic measurement: ventricular function, ventricular longitudinal strain, diastolic parameters, presence of valvular disease, change in systemic ventricular filling profile after exercise and the following measurements will be analyzed:
- MPO-DNA (UA/mL)
- Citrullinated histone (optic density unit)
- Elastase (pg/mL)
- Calprotectine (pg/mL)
- MMP9 (pg/mL)
- NGAL (pg/mL)
- MPO (UA/mL)
- IL-8 (pg/ml)
Measured: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to measurement of myocardial stiffness.
The association between myocardial stiffness (in KPa, measured with ultrafast cardiac echography) and the following measurements will be analyzed :
- MPO-DNA (UA/mL)
- Citrullinated histone (optic density unit)
- Elastase (pg/mL)
- Calprotectine (pg/mL)
- MMP9 (pg/mL)
- NGAL (pg/mL)
- MPO (UA/mL)
- IL-8 (pg/ml)
Measured: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to volumes, masses and ventricular ejection fraction, late enhancement and T1 measurement
The association between each parameters of cardiac magnetic resonance imaging: volumes, masses and ventricular ejection fraction, late enhancement and T1 measurement and the following measurements will be analyzed :
- MPO-DNA (UA/mL)
- Citrullinated histone (optic density unit)
- Elastase (pg/mL)
- Calprotectine (pg/mL)
- MMP9 (pg/mL)
- NGAL (pg/mL)
- MPO (UA/mL)
- IL-8 (pg/ml)
Measured: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to biological markers: BNP, CRPus, troponin, biomarkers of collagen metabolism.
The association between each biological markers: BNP (pg/ml), CRPus (mg/L), troponin (ng/L), biomarkers of collagen metabolism (PICP (ng/Ml), P3NP (ng/ml), ICTP (microgr/L), MMP1 (ng/ml), TIMP1 (ng/ml), galactine 3 (ng/ml)) and the following measurements will be analyzed :
- MPO-DNA (UA/mL)
- Citrullinated histone (optic density unit)
- Elastase (pg/mL)
- Calprotectine (pg/mL)
- MMP9 (pg/mL)
- NGAL (pg/mL)
- MPO (UA/mL)
- IL-8 (pg/ml)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start22 Feb 2022
- Primary completion23 Feb 2025 (estimated)
- Study completion23 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, European Commission
- Responsible party
- Sponsor
- Investigators
- Magalie Ladouceur, Pr, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263843
- Sponsor's protocol ID
- APHP211359
- Acronym
- FIBRONETx
- Status last verified
- Jan 2023
- First submitted
- 9 Feb 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Publications
Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007 Jan 16;115(2):163-72. doi: 10.1161/CIRCULATIONAHA.106.627224. Epub 2007 Jan 8.
PubMed 17210844Burchill LJ, Broberg CS, Maxwell BG, McLarry J, Opotowskuy S. National Heart Failure Admissions and Associated Mortality Trends in Adults With Congenital Heart Disease in the United States, 1998-2011. J Heart Lung Transplant. 1 avr 2015;34(4):S155.
Moussa NB, Karsenty C, Pontnau F, Malekzadeh-Milani S, Boudjemline Y, Legendre A, Bonnet D, Iserin L, Ladouceur M. Characteristics and outcomes of heart failure-related hospitalization in adults with congenital heart disease. Arch Cardiovasc Dis. 2017 May;110(5):283-291. doi: 10.1016/j.acvd.2017.01.008. Epub 2017 Mar 14.
PubMed 28314706Diller G-P. Incidence and Prevalence of Heart Failure in Adults with Congenital Heart Disease. In: Swan L, Frogoudaki AA, éditeurs. Heart Failure in Adult Congenital Heart Disease [Internet]. Cham: Springer International Publishing; 2018. p. 3-9. (Congenital Heart Disease in Adolescents and Adults). Disponible sur: https://doi.org/10.1007/978-3-319-77803-7_1
Khairy P, Fernandes SM, Mayer JE Jr, Triedman JK, Walsh EP, Lock JE, Landzberg MJ. Long-term survival, modes of death, and predictors of mortality in patients with Fontan surgery. Circulation. 2008 Jan 1;117(1):85-92. doi: 10.1161/CIRCULATIONAHA.107.738559. Epub 2007 Dec 10.
PubMed 18071068Engelings CC, Helm PC, Abdul-Khaliq H, Asfour B, Bauer UM, Baumgartner H, Kececioglu D, Korten MA, Diller GP, Tutarel O. Cause of death in adults with congenital heart disease - An analysis of the German National Register for Congenital Heart Defects. Int J Cardiol. 2016 May 15;211:31-6. doi: 10.1016/j.ijcard.2016.02.133. Epub 2016 Mar 2.
PubMed 26970963Diller GP, Kempny A, Alonso-Gonzalez R, Swan L, Uebing A, Li W, Babu-Narayan S, Wort SJ, Dimopoulos K, Gatzoulis MA. Survival Prospects and Circumstances of Death in Contemporary Adult Congenital Heart Disease Patients Under Follow-Up at a Large Tertiary Centre. Circulation. 2015 Dec 1;132(22):2118-25. doi: 10.1161/CIRCULATIONAHA.115.017202. Epub 2015 Sep 14.
PubMed 26369353Zomer AC, Vaartjes I, van der Velde ET, de Jong HM, Konings TC, Wagenaar LJ, Heesen WF, Eerens F, Baur LH, Grobbee DE, Mulder BJ. Heart failure admissions in adults with congenital heart disease; risk factors and prognosis. Int J Cardiol. 2013 Oct 3;168(3):2487-93. doi: 10.1016/j.ijcard.2013.03.003. Epub 2013 Apr 18.
PubMed 23602867Wang F, Liu A, Brophy JM, Cohen S, Abrahamowicz M, Paradis G, Marelli A. Determinants of Survival in Older Adults With Congenital Heart Disease Newly Hospitalized for Heart Failure. Circ Heart Fail. 2020 Aug;13(8):e006490. doi: 10.1161/CIRCHEARTFAILURE.119.006490. Epub 2020 Jul 16.
PubMed 32673500Ghali JK, Krause-Steinrauf HJ, Adams KF, Khan SS, Rosenberg YD, Yancy CW, Young JB, Goldman S, Peberdy MA, Lindenfeld J. Gender differences in advanced heart failure: insights from the BEST study. J Am Coll Cardiol. 2003 Dec 17;42(12):2128-34. doi: 10.1016/j.jacc.2003.05.012.
PubMed 14680739Zomer AC, Ionescu-Ittu R, Vaartjes I, Pilote L, Mackie AS, Therrien J, Langemeijer MM, Grobbee DE, Mulder BJ, Marelli AJ. Sex differences in hospital mortality in adults with congenital heart disease: the impact of reproductive health. J Am Coll Cardiol. 2013 Jul 2;62(1):58-67. doi: 10.1016/j.jacc.2013.03.056. Epub 2013 May 1.
PubMed 23644083
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Différences de Genre Dans l'Activation Des NET et Son Implication Dans la Formation de Fibrose Cardiaques Chez Les Patients Adultes Avec Une Cardiopathie congénitale Complexe FIBRONETx Gender
- ClinicalTrials.gov ID
- NCT05263843
- Acronym / sponsor ID
- FIBRONETx / APHP211359
- Conditions
- Congenital Heart Disease, Heart Failure, Gender
- Keywords
- Congenital heart disease, Heart failure, Gender, Fibrosis, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France, European Commission
- Study start
- 22 Feb 2022 (actual)
- Primary completion
- 23 Feb 2025 (estimated)
- Study completion
- 23 Feb 2025 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 clinical symptoms in cardiovascular disease compared to men. A cardioprotective effect in women has been suggested in some studies including patients with congenital heart disease (CHD) and heart failure. Our hypothesis is that estrogen protects the hearts of female patients aged 18-45 with CHD. There is no information available as to the involvement of neutrophils in heart failure in females compared to male patients, and therefore this study will provide important information for both the CHD and neutrophil biology fields comparing NET activation in women and men with severe CHD.
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 identified as a risk factor for heart failure, will be included. A control group of 50 patients (25 men and 25 women) were matched on age and sex.
The main objective of the study is to study the difference in NET activation between men and women with complex congenital heart disease.
Secondary objectives are:
- To compare the NET activity between healthy subjects vs. patients at inclusion.
- To compare male vs. female NET activity in healthy subjects at inclusion.
- To study the existence of associations of NET with biomarkers of fibrosis (biological and imaging) at baseline in men and women with complex congenital heart disease.
- To study the protective value of pregnancy on inflammatory mechanisms and the formation of fibrosis involved in impaired ventricular function and heart failure in these patients.
The enrolled patients will have blood samples collected for analysis of PAD4/NETs biomarkers, and fibrosis markers. NET/fibrosis markers will be correlated with clinical/laboratory parameters, notably NET/PAD4 levels with markers of fibrosis such as collagen biomarkers, ECG, echocardiographic, and cardiac magnetic resonance imaging biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Biological markers of myocardial fibrosisPatients with a complex congenital heart disease |
| controls | – | Diagnostic Test: Biological markers of myocardial fibrosishealthy subjects |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will therefore be represented by: * heart diseases at risk of heart failure with an equal proportion of men and women to be able to study the protective character of the female sex on the inflammatory process and the development of myocardial fibrosis. * healthy adult subjects.
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological markers of myocardial fibrosisBlood sample for measurements of NET activation and collagen biomarkers | Diagnostic test | Patients, controls |
Primary outcome
NET activation levels and PAD4 Levels
Time frame: baseline
Measurements of MPO-DNA, citrullinated histone, Elastase, Calprotectine, MMP9, NGAL, and MPO, IL-8
6 secondary outcomes
The association of NET / PAD4 biomarker levels will be analyzed to NYHA functional class.
Time frame: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to QRS width and late potentials.
Time frame: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to ventricular function, ventricular longitudinal strain, diastolic parameters, presence of valvular disease, change in systemic ventricular filling profile after exercise
Time frame: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to measurement of myocardial stiffness.
Time frame: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to volumes, masses and ventricular ejection fraction, late enhancement and T1 measurement
Time frame: baseline
The association of NET / PAD4 biomarker levels will be analyzed in relation to biological markers: BNP, CRPus, troponin, biomarkers of collagen metabolism.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Background: PubMed 17210844Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007 Jan 16;115(2):163-72. doi: 10.1161/CIRCULATIONAHA.106.627224. Epub 2007 Jan 8.
- BackgroundBurchill LJ, Broberg CS, Maxwell BG, McLarry J, Opotowskuy S. National Heart Failure Admissions and Associated Mortality Trends in Adults With Congenital Heart Disease in the United States, 1998-2011. J Heart Lung Transplant. 1 avr 2015;34(4):S155.
- Background: PubMed 28314706Moussa NB, Karsenty C, Pontnau F, Malekzadeh-Milani S, Boudjemline Y, Legendre A, Bonnet D, Iserin L, Ladouceur M. Characteristics and outcomes of heart failure-related hospitalization in adults with congenital heart disease. Arch Cardiovasc Dis. 2017 May;110(5):283-291. doi: 10.1016/j.acvd.2017.01.008. Epub 2017 Mar 14.
- BackgroundDiller G-P. Incidence and Prevalence of Heart Failure in Adults with Congenital Heart Disease. In: Swan L, Frogoudaki AA, éditeurs. Heart Failure in Adult Congenital Heart Disease [Internet]. Cham: Springer International Publishing; 2018. p. 3-9. (Congenital Heart Disease in Adolescents and Adults). Disponible sur: https://doi.org/10.1007/978-3-319-77803-7_1
- Background: PubMed 18071068Khairy P, Fernandes SM, Mayer JE Jr, Triedman JK, Walsh EP, Lock JE, Landzberg MJ. Long-term survival, modes of death, and predictors of mortality in patients with Fontan surgery. Circulation. 2008 Jan 1;117(1):85-92. doi: 10.1161/CIRCULATIONAHA.107.738559. Epub 2007 Dec 10.
- Background: PubMed 26970963Engelings CC, Helm PC, Abdul-Khaliq H, Asfour B, Bauer UM, Baumgartner H, Kececioglu D, Korten MA, Diller GP, Tutarel O. Cause of death in adults with congenital heart disease - An analysis of the German National Register for Congenital Heart Defects. Int J Cardiol. 2016 May 15;211:31-6. doi: 10.1016/j.ijcard.2016.02.133. Epub 2016 Mar 2.
- Background: PubMed 26369353Diller GP, Kempny A, Alonso-Gonzalez R, Swan L, Uebing A, Li W, Babu-Narayan S, Wort SJ, Dimopoulos K, Gatzoulis MA. Survival Prospects and Circumstances of Death in Contemporary Adult Congenital Heart Disease Patients Under Follow-Up at a Large Tertiary Centre. Circulation. 2015 Dec 1;132(22):2118-25. doi: 10.1161/CIRCULATIONAHA.115.017202. Epub 2015 Sep 14.
- Background: PubMed 23602867Zomer AC, Vaartjes I, van der Velde ET, de Jong HM, Konings TC, Wagenaar LJ, Heesen WF, Eerens F, Baur LH, Grobbee DE, Mulder BJ. Heart failure admissions in adults with congenital heart disease; risk factors and prognosis. Int J Cardiol. 2013 Oct 3;168(3):2487-93. doi: 10.1016/j.ijcard.2013.03.003. Epub 2013 Apr 18.
- Background: PubMed 32673500Wang F, Liu A, Brophy JM, Cohen S, Abrahamowicz M, Paradis G, Marelli A. Determinants of Survival in Older Adults With Congenital Heart Disease Newly Hospitalized for Heart Failure. Circ Heart Fail. 2020 Aug;13(8):e006490. doi: 10.1161/CIRCHEARTFAILURE.119.006490. Epub 2020 Jul 16.
- Background: PubMed 14680739Ghali JK, Krause-Steinrauf HJ, Adams KF, Khan SS, Rosenberg YD, Yancy CW, Young JB, Goldman S, Peberdy MA, Lindenfeld J. Gender differences in advanced heart failure: insights from the BEST study. J Am Coll Cardiol. 2003 Dec 17;42(12):2128-34. doi: 10.1016/j.jacc.2003.05.012.
- Background: PubMed 23644083Zomer AC, Ionescu-Ittu R, Vaartjes I, Pilote L, Mackie AS, Therrien J, Langemeijer MM, Grobbee DE, Mulder BJ, Marelli AJ. Sex differences in hospital mortality in adults with congenital heart disease: the impact of reproductive health. J Am Coll Cardiol. 2013 Jul 2;62(1):58-67. doi: 10.1016/j.jacc.2013.03.056. Epub 2013 May 1.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magalie Ladouceur, Pr principal investigator
Hôpital Européen Georges-Pompidou
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magalie Ladouceur, Pr (0033608260618, magalie.ladouceur@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NET activation levels and PAD4 Levels (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263843, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.