Clinical trial NCT03235063: Pregnancy and Dilated Cardiomyopathy
Official title: Registry of Pregnancy Follow-up in Patients With Dilated Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dilated Cardiomyopathy
Keywords: Dilated cardiomyopathy
registry
heart failure
pregnancy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with dilated cardiomyopathy

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.

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

Primary outcomes:
measure: evaluate clinical characteristics
timeFrame: Jan 2018
measure: study maternal
timeFrame: Jan 2018
measure: neonatal evolution
timeFrame: Jan 2018
measure: complications during pregnancy
timeFrame: Jan 2018
Secondary outcomes:
measure: quarterly blood rate of Brain Natriuretic Peptide (BNP)
timeFrame: Jan 2018
measure: quarterly blood rate of N-Terminal pro-Brain Natriuretic Peptide (NTproBNP)
timeFrame: Jan 2018
measure: quarterly evolution of left ventricular ejection fraction
timeFrame: Jan 2018
measure: left ventricular ejection diameter
timeFrame: Jan 2018
measure: treatment before and during the pregnancy
timeFrame: Jan 2018
measure: modalities of medical attention during delivery
timeFrame: Jan 2018
measure: modalities of mother medical attention during peripartum
timeFrame: Jan 2018
measure: modalities of new-born medical attention
timeFrame: Jan 2018
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Brest
country: France
facility: Chru de Brest
city: Créteil
country: France
facility: Hospital Henri Mondor
city: Lille
country: France
facility: Chru Lille
city: Marseille
country: France
facility: AP-HM
city: Nancy
country: France
facility: Chu Nancy
city: Nantes
country: France
facility: CHU de NANTES
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: Hospital Salpetrière
city: Paris
country: France
facility: Hegp Pompidou
city: Paris
country: France
facility: Hospital Lariboisière
city: Paris
country: France
facility: Ap-Hp Bichat
city: Rennes
country: France
facility: Chu Rennes
city: Rouen
country: France
facility: Chu Rouen
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: Nantes University Hospital
name: Jean-Noel TROCHU, pu-ph
role: PRINCIPAL_INVESTIGATOR
References: