A Registry of Peripartum Cardiomyopathy in Turkey

Peripartum Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03364140
• Other study ID #: TKD-PPKM
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2017
• Last updated: December 4, 2017
• Start date: July 2, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: December 2017
• Source: Ege University
• Contact: Meral Kayikcioglu, MD
• Phone: +902323905448
• Email: meral.kayikcioglu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Peripartum Cardiomyopathy

Locations

Country	Name	City	State
Turkey	Koc University Medical School Cardiology Department	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Turkish Society of Cardiology

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy outcome	mortality of the mother	5 months after delivery