A Registry of Peripartum Cardiomyopathy in Turkey

December 4, 2017 updated by: Meral Kayikcioglu, Ege University

Clinical A Nation-wide Registry of Peripartum Cardiomyopathy: Clinical Status in Turkey

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

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

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Koc University Medical School Cardiology Department
        • Contact:

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

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy outcome
Time Frame: 5 months after delivery
mortality of the mother
5 months after delivery

Collaborators and Investigators

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

Sponsor

Ege University

Collaborators

Turkish Society of Cardiology

Investigators

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

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)

July 2, 2017

Primary Completion (ANTICIPATED)

January 15, 2018

Study Completion (ANTICIPATED)

January 15, 2018

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (ACTUAL)

December 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKD-PPKM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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