Peripartum CardiomyopathyNCT03364140
A Registry of Peripartum Cardiomyopathy in Turkey
An observational study of Peripartum Cardiomyopathy, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Peripartum Cardiomyopathy
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jul 2017to 15 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- 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
Who may be able to join
- 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
Who cannot join
- Patients with any other known cardiac pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University Medical School Cardiology Department
Istanbul
Dilek Ural, MD, duralk@tkd.org.tr
About this study
Official title: 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.
Read the 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
- Conditions
- Peripartum Cardiomyopathy
- Keywords
- Peripartum Cardiomyopathy, Heart Failure
- Medical subject headings
- Peripartum Cardiomyopathy, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome
mortality of the mother
Measured: 5 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start2 Jul 2017
- Primary completion15 Jan 2018 (estimated)
- Study completion15 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripartum CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Society of Cardiology
- Responsible party
- Principal investigator, Meral Kayikcioglu, Ege University
- Investigators
- Dilek Ural, MD, Study director, Koc University Medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364140
- Sponsor's protocol ID
- TKD-PPKM
- Status last verified
- Dec 2017
- First submitted
- 9 Aug 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical A Nation-wide Registry of Peripartum Cardiomyopathy: Clinical Status in Turkey
- ClinicalTrials.gov ID
- NCT03364140
- Acronym / sponsor ID
- TKD-PPKM
- Conditions
- Peripartum Cardiomyopathy
- Keywords
- Peripartum Cardiomyopathy, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Turkish Society of Cardiology
- Study start
- 2 Jul 2017 (actual)
- Primary completion
- 15 Jan 2018 (estimated)
- Study completion
- 15 Jan 2018 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with any other known cardiac pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy outcome
Time frame: 5 months after delivery
mortality of the mother
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Ural, MD study director
Koc University Medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripartum Cardiomyopathy, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meral Kayikcioglu, MD (+902323905448, meral.kayikcioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcome (time frame: 5 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.