Pregnancy and Dilated Cardiomyopathy

September 8, 2021 updated by: Nantes University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Jan 2018
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.
Jan 2018
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.
Jan 2018
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.
Jan 2018

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Jan 2018
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
Jan 2018
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
Jan 2018
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
Jan 2018
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
Jan 2018
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
Jan 2018
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
Jan 2018
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
Jan 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Noel TROCHU, pu-ph, CHU de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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