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A Registry of Peripartum Cardiomyopathy in Turkey

Sponsor
Ege University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03364140
Collaborator
Turkish Society of Cardiology (Other)
50
Enrollment
1
Location
6.5
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Jul 2, 2017
    Anticipated Primary Completion Date :
    Jan 15, 2018
    Anticipated Study Completion Date :
    Jan 15, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy outcome [5 months after delivery]

      mortality of the mother

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Koc University Medical School Cardiology Department Istanbul Turkey

    Sponsors and Collaborators

    • Ege University
    • Turkish Society of Cardiology

    Investigators

    • Study Director: Dilek Ural, MD, Koc University Medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meral Kayikcioglu, Prof Dr, Ege University
    ClinicalTrials.gov Identifier:
    NCT03364140
    Other Study ID Numbers:
    • TKD-PPKM
    First Posted:
    Dec 6, 2017
    Last Update Posted:
    Dec 6, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meral Kayikcioglu, Prof Dr, Ege University
    Peripartum Cardiomyopathy
    Heart Failure
    Additional relevant MeSH terms:
    Cardiomyopathies

    Study Results

    No Results Posted as of Dec 6, 2017