Pregnancy and Dilated Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-02

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accuracy of Risk Prediction Scores in Pregnant Women

NCT04221048

Congenital Heart Disease Pregnancy

COMPLETED

Pregnancy in GUCH Patients

NCT06574386

Congenital Heart Disease Pregnancy Related Infant Development +2 more

NOT_YET_RECRUITING NA

Registry and Survey of Women With Pregnancy Related Cardiomyopathy

NCT00273637

Cardiomyopathy Pregnancy-Associated Cardiomyopathy Heart Failure

UNKNOWN

Fetal Growth and Pregnancy Complications Among Women With Heart Disease

NCT03657823

Congenital Heart Disease Pregnancy Complications Arrhythmias, Cardiac +1 more

UNKNOWN

NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

NCT04231591

Congenital Heart Disease Pregnancy Complications

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dilated Cardiomyopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

routinely care- no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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