Pregnancy and Dilated Cardiomyopathy

Registry of Pregnancy Follow-up in Patients With 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.

Study Overview

• Status: Completed
• Conditions: Dilated Cardiomyopathy
• Intervention / Treatment: Other: routinely care- no intervention

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.

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers
  • Brest, France, 29609
    • CHRU de Brest
  • Créteil, France, 94010
    • Hospital Henri Mondor
  • Lille, France, 59000
    • CHRU Lille
  • Marseille, France, 13000
    • AP-HM
  • Nancy, France, 54035
    • CHU Nancy
  • Nantes, France, 44093
    • CHU de Nantes
  • Nice, France, 06003
    • CHU Nice
  • Paris, France, 75013
    • Hospital Salpétrière
  • Paris, France, 75015
    • Hegp Pompidou
  • Paris, France, 75475
    • Hospital Lariboisière
  • Paris, France
    • AP-HP Bichat
  • Rennes, France, 35000
    • CHU Rennes
  • Rouen, France, 76000
    • CHU Rouen
  • Toulouse, France, 31059
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women with dilated cardiomyopathy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate clinical characteristics	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.	Jan 2018
study maternal	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.	Jan 2018
neonatal evolution	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.	Jan 2018
complications during pregnancy	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.	Jan 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quarterly blood rate of Brain Natriuretic Peptide (BNP)	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	Jan 2018
quarterly blood rate of N-Terminal pro-Brain Natriuretic Peptide (NTproBNP)	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	Jan 2018
quarterly evolution of left ventricular ejection fraction	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	Jan 2018
left ventricular ejection diameter	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	Jan 2018
treatment before and during the pregnancy	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	Jan 2018
modalities of medical attention during delivery	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	Jan 2018
modalities of mother medical attention during peripartum	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	Jan 2018
modalities of new-born medical attention	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	Jan 2018

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Jean-Noel TROCHU, pu-ph, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2013
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; heart failure; registry; Dilated cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: Prog/10/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No