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A Registry of Peripartum Cardiomyopathy in Turkey

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ClinicalTrials.gov Identifier: NCT03364140
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Turkish Society of Cardiology
Information provided by (Responsible Party):
Meral Kayikcioglu, Ege University

Brief Summary:
Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality of young women. Its' etiology, epidemiology and treatment is not yet well described. This will be a retrospective, national, multicenter observational study, conducted in Turkey. It is expected that approximately 50 women with PPCM will be recorded.

Condition or disease
Peripartum Cardiomyopathy

Detailed Description:

Peripartum cardiomyopathy (PPCM) is a global disease with significant morbidity and mortality of young women. Its' etiology, epidemiology and treatment is not yet well described. This will be a retrospective, national, multicenter observational study, conducted in centres in Turkey. It is expected that approximately 50 women with PPCM will be recorded.

The objectives of the study are:

To define the clinical status and clinical characteristics of PPCM in Turkey

To define the outcome of PPCM (short and long term)

To define the demographical and possible etiological factors

To define prognostic factors


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical A Nation-wide Registry of Peripartum Cardiomyopathy: Clinical Status in Turkey
Actual Study Start Date : July 2, 2017
Estimated Primary Completion Date : January 15, 2018
Estimated Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy




Primary Outcome Measures :
  1. Pregnancy outcome [ Time Frame: 5 months after delivery ]
    mortality of the mother



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female aged >18 years
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients with unexplained Heart Failure symptoms developed towards the end of pregnancy or in the first 6 months of postpartum period
Criteria

Inclusion Criteria:

  • Patient above 18 years of age
  • Unexplained Heart Failure symptoms developed towards the end of pregnancy or in the first 6 months of postpartum period
  • Ejection fraction less than 45% documented with echocardiography

Exclusion Criteria:

  • Patients with any other known cardiac pathology

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): NCT03364140


Contacts
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Contact: Meral Kayikcioglu, MD +902323905448 meral.kayikcioglu@gmail.com
Contact: Meral Kayikcioglu +902323905448 meral.kayikcioglu@gmail.com

Locations
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Turkey
Koc University Medical School Cardiology Department Recruiting
Istanbul, Turkey
Contact: Dilek Ural, MD       duralk@tkd.org.tr   
Sponsors and Collaborators
Ege University
Turkish Society of Cardiology
Investigators
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Study Director: Dilek Ural, MD Koc University Medical school

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Responsible Party: Meral Kayikcioglu, Prof Dr, Ege University
ClinicalTrials.gov Identifier: NCT03364140     History of Changes
Other Study ID Numbers: TKD-PPKM
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Meral Kayikcioglu, Ege University:
Peripartum Cardiomyopathy
Heart Failure
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases