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NCT Number: NCT03235063

Pregnancy and Dilated Cardiomyopathy

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.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Laminopathies

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chu Angers, Angers, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

routinely care- no intervention

Other

routinely care- no intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. quarterly blood rate of Brain Natriuretic Peptide (BNP)

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

  2. quarterly blood rate of N-Terminal pro-Brain Natriuretic Peptide (NTproBNP)

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

  3. quarterly evolution of left ventricular ejection fraction

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

  4. left ventricular ejection diameter

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

  5. treatment before and during the pregnancy

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

  6. modalities of medical attention during delivery

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

  7. modalities of mother medical attention during peripartum

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

  8. modalities of new-born medical attention

    Time frame: Jan 2018

    Analyse specific data of the pregnancy follow-up such as quarterly blood rate of Brain Natriuretic Peptide (BNP) or N-Terminal pro-Brain Natriuretic Peptide (NTproBNP) and cardiac echography for quarterly evolution of left ventricular ejection fraction and diameter measurement Analyse treatment before and during the pregnancy Analyse modalities of medical attention during delivery Analyse modalities of mother medical attention during peripartum Analyse modalities of new-born medical attention

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Registry of Pregnancy Follow-up in Patients With Dilated Cardiomyopathy

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Aug 1, 2017
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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