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Trial record 13 of 157 for:    Idiopathic Dilated Cardiomyopathy

Pregnancy and Dilated Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235063
Recruitment Status : Unknown
Verified August 2017 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : August 1, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment
Dilated Cardiomyopathy 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Registry of Pregnancy Follow-up in Patients With Dilated Cardiomyopathy
Actual Study Start Date : January 2, 2013
Estimated Primary Completion Date : January 2, 2018
Estimated Study Completion Date : June 1, 2018



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
pregnant women with dilated cardiomyopathy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235063


Contacts
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Contact: Jean-Noel TROCHU, pu-ph 33 2 40 16 52 74 jeannoel.trochu@chu-nantes.fr
Contact: Swanny Fouchard swanny.fouchard@chu-nantes.fr

Locations
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France
Chu Angers Recruiting
Angers, France, 49100
Contact: Frédéric ROULEAU         
Chru de Brest Recruiting
Brest, France, 29609
Contact: Yves ETIENNE         
Hospital Henri Mondor Recruiting
Créteil, France, 94010
Contact: Thibaud DAMY, PU-PH    01 49 81 26 87      
Chru Lille Recruiting
Lille, France, 59000
Contact: Frédéric MOUQUET         
AP-HM Recruiting
Marseille, France, 13000
Contact: Gilbert HABIB, PU-PH    04 91 38 75 88      
Chu Nancy Recruiting
Nancy, France, 54035
Contact: Yves JUILLERES         
CHU de NANTES Recruiting
Nantes, France, 44093
Contact: Jean-Noël TROCHU, PU-PH    33 2 40 16 52 74    jeannoel.trochu@chu-nantes.fr   
Contact: Swanny Fouchard       swanny.fouchard@chu-nantes.fr   
CHU NICE Recruiting
Nice, France, 06003
Contact: Pierre GIBELIN         
Hospital Salpetrière Recruiting
Paris, France, 75013
Contact: Richard ISNARD, PU-PH         
Contact: Philippe CHARRON, PH         
Hegp Pompidou Recruiting
Paris, France, 75015
Contact: Michel Desnos, PH    01 56 09 37 23      
Hospital Lariboisière Recruiting
Paris, France, 75475
Contact: Damien logeart         
Ap-Hp Bichat Recruiting
Paris, France
Contact: Guillaume JONDEAU, PU-PH    01 40 25 88 11    guillaume.jondeau@bch.ap-hop-paris.fr   
Chu Rennes Recruiting
Rennes, France, 35000
Contact: Erwan DOWAL         
Chu Rouen Recruiting
Rouen, France, 76000
Contact: Fabrice BAUER         
Chu Toulouse Recruiting
Toulouse, France, 31059
Contact: Michel GALINIER         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Jean-Noel TROCHU, pu-ph CHU de NANTES

Additional Information:

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03235063     History of Changes
Other Study ID Numbers: Prog 10/17
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Dilated cardiomyopathy
registry
heart failure
pregnancy
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly