Pregnancy and Dilated Cardiomyopathy

Dilated Cardiomyopathy Clinical Trial

Official title:

Registry of Pregnancy Follow-up in Patients With Dilated Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235063
• Other study ID #: Prog/10/17
• Status: Completed
• Start date: January 2, 2013
• Est. completion date: June 30, 2021

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Other:
• routinely care- no intervention
routinely care- no intervention

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Chru de Brest	Brest
France	Hospital Henri Mondor	Créteil
France	Chru Lille	Lille
France	AP-HM	Marseille
France	Chu Nancy	Nancy
France	CHU de NANTES	Nantes
France	CHU NICE	Nice
France	Ap-Hp Bichat	Paris
France	Hegp Pompidou	Paris
France	Hospital Lariboisière	Paris
France	Hospital Salpetrière	Paris
France	Chu Rennes	Rennes
France	Chu Rouen	Rouen
France	Chu Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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