A Registry of Peripartum Cardiomyopathy in Turkey | NCT03364140

Studies
A Registry of Peripartum Cardiomyopathy in Turkey

NCT03364140

Sponsor

Ege University

Status

Unknown status

Last Update Posted

Dec 6, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Peripartum Cardiomyopathy

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2017Actual

Primary Completion Date

Jan 15, 2018Estimated

Completion Date

Jan 15, 2018Estimated

First Submitted Date

Aug 9, 2017

First Submission Date that Met QC Criteria

Dec 4, 2017

First Posted Date

Dec 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2017

Last Update Posted Date

Dec 6, 2017Actual

Name	Class
Turkish Society of Cardiology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female aged >18 years

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Female patients with unexplained Heart Failure symptoms developed towards the end of pregnancy or in the first 6 months of postpartum period

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meral Kayikcioglu, MD	Contact	+902323905448		meral.kayikcioglu@gmail.com
Meral Kayikcioglu	Contact	+902323905448		meral.kayikcioglu@gmail.com

Overall Officials

Name	Affiliation	Role
Dilek Ural, MD	Koc University Medical school	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Koc University Medical School Cardiology Department	Recruiting	Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000099088	Peripartum Cardiomyopathy
D006333	Heart Failure

Ancestor Terms

ID	Term
D011249	Pregnancy Complications, Cardiovascular
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided