NCT03364140

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

August 9, 2017

Last Update Submit

December 4, 2017

Conditions

Keywords

Peripartum CardiomyopathyHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Pregnancy outcome

    mortality of the mother

    5 months after delivery

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale aged \>18 years
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with any other known cardiac pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University Medical School Cardiology Department

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Peripartum CardiomyopathyHeart Failure

Condition Hierarchy (Ancestors)

Pregnancy Complications, CardiovascularPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Officials

  • Dilek Ural, MD

    Koc University Medical school

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

August 9, 2017

First Posted

December 6, 2017

Study Start

July 2, 2017

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

December 6, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations