Registry of Pregnancy Follow-up in Patients With Dilated Cardiomyopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dilated Cardiomyopathy
- Sponsor
- Nantes University Hospital
- Enrollment
- 42
- Locations
- 15
- Primary Endpoint
- evaluate clinical characteristics
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Increasing cases of women with dilated cardiomyopathy with a project of pregnancy are observed. However there is few knowledge and publications about cardiac diseases in pregnant women. Moreover the majority of medical articles deal with women with congenital heart diseases, valvular pathologies or peripartum cardiomyopathies, and few data are available in literature about women with dilated cardiomyopathy diagnosed before or during the first months of the pregnancy.
Cardiologist and obstetrician advices are considerably limited when patients with dilated cardiomyopathy have a pregnancy project. Knowledges and know-how are currently based on limited personal experiment or on few clinical cases descriptions.
Pregnancy represents a high-risk situation for patients with dilated cardiomyopathy. Creation of a cohort of pregnant women with dilated cardiomyopathy collecting specific data will allow to have a better overview and to appreciate possibilities of a pregnancy project, evolution risks and modalities for medical attention and to improve follow-up and advices delivered to these patients.
Detailed Description
This study is a national (20 centres) retrospective (10 years) and prospective registry of pregnant women with dilated cardiomyopathy. As this study is observational, medical attention of the enrolled patients will not be modified. No specific visit is planned for the study. Before the enrolment of the patient, the investigator provides the subject with clear and precise information about the protocol and requests her for written informed consent. The French ethical committee gave the investigators the possibility to include women in the registry if the investigators are unable to inform her (deceased women, no follow-up). The main objective of the study is to evaluate clinical characteristics and study maternal and neonatal evolution and complications during pregnancy using analysis of the morbi-mortality and clinical and para clinical criteria. The following data will be compiled in a case report form (e-CRF): * Risk factors, cardiac history * BNP or NTproBNP value, echocardiographic data (LVEF and LV diameter) * Medical treatment before and during the pregnancy * complications; occurrences during the pregnancy * Modalities of medical attention during delivery: mother/child Patient's data are coded, and therefore anonymous, by using the inclusion number and initials of the patient (first letter of name and first letter of surname (ex: 01-X_X). In this prospective and retrospective, multi-centre, clinical study, all patients enrolled in the cohort will be included in the statistical analysis. As an observational non-randomized single arm evaluation, the statistical analyses will be descriptive. A minimum of 100 patients will be enrolled.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients over the age of majority
- •Followed-up for non-ischemic left heart failure, diagnosed before or during the pregnancy or with peripartum history, with a left ventricular ejection fraction \< 50% and/or a left ventricle diameter \> 27 mm/m2
- •In New York Heart Association (NYHA) class 1 to 4
- •Pregnant or with pregnancy history
- •Patients with left ventricular non-compaction, valvular cardiomyopathy operated or not can also be enrolled
Exclusion Criteria
- •Refusal for participation
- •Ischemic, hypertrophic, restrictive and congenital cardiomyopathies
Outcomes
Primary Outcomes
evaluate clinical characteristics
Time Frame: Jan 2018
Purpose is to realise a French cohort of pregnancies in patients with dilated cardiomyopathy to evaluate clinical characteristics, study maternal and neonatal evolution and complications during pregnancy.
study maternal
Time Frame: Jan 2018
Purpose is to realise a French cohort of pregnancies in patients with dilated cardiomyopathy to evaluate clinical characteristics, study maternal and neonatal evolution and complications during pregnancy.
neonatal evolution
Time Frame: Jan 2018
Purpose is to realise a French cohort of pregnancies in patients with dilated cardiomyopathy to evaluate clinical characteristics, study maternal and neonatal evolution and complications during pregnancy.
complications during pregnancy
Time Frame: Jan 2018
Purpose is to realise a French cohort of pregnancies in patients with dilated cardiomyopathy to evaluate clinical characteristics, study maternal and neonatal evolution and complications during pregnancy.
Secondary Outcomes
- quarterly blood rate of Brain Natriuretic Peptide (BNP)(Jan 2018)
- quarterly blood rate of N-Terminal pro-Brain Natriuretic Peptide (NTproBNP)(Jan 2018)
- quarterly evolution of left ventricular ejection fraction(Jan 2018)
- left ventricular ejection diameter(Jan 2018)
- modalities of medical attention during delivery(Jan 2018)
- modalities of mother medical attention during peripartum(Jan 2018)
- treatment before and during the pregnancy(Jan 2018)
- modalities of new-born medical attention(Jan 2018)