Pregnancy and Dilated Cardiomyopathy

NCT03235063 | Completed

• 1 other identifier: Prog/10/17
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 15

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.

Conditions

Dilated Cardiomyopathy

Keywords

Dilated cardiomyopathy; registry; heart failure; pregnancy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• quarterly blood rate of Brain Natriuretic Peptide (BNP)

  Jan 2018

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

  Jan 2018

• quarterly evolution of left ventricular ejection fraction

  Jan 2018

• left ventricular ejection diameter

  Jan 2018

• treatment before and during the pregnancy

  Jan 2018

Interventions

routinely care- no intervention OTHER

routinely care- no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women with dilated cardiomyopathy

You may qualify if:

• 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

You may not qualify if:

• Refusal for participation
• Ischemic, hypertrophic, restrictive and congenital cardiomyopathies

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (15)

Chu Angers

Angers, 49100, France

Location

Chru de Brest

Brest, 29609, France

Location

Hospital Henri Mondor

Créteil, 94010, France

Location

Chru Lille

Lille, 59000, France

Location

AP-HM

Marseille, 13000, France

Location

Chu Nancy

Nancy, 54035, France

Location

CHU de NANTES

Nantes, 44093, France

Location

CHU NICE

Nice, 06003, France

Location

Hospital Salpetrière

Paris, 75013, France

Location

Hegp Pompidou

Paris, 75015, France

Location

Hospital Lariboisière

Paris, 75475, France

Location

Ap-Hp Bichat

Paris, France

Location

Chu Rennes

Rennes, 35000, France

Location

Chu Rouen

Rouen, 76000, France

Location

Chu Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jean-Noel TROCHU, pu-ph

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: January 2, 2013
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

FR (15)