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Registry and Survey of Women With Pregnancy Related Cardiomyopathy

NCT ID: NCT00273637

Last Updated: 2006-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-01-31

Brief Summary

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The goal of this study is to better characterize peripartum cardiomyoapthy or pregnancy-related cardiomyopathy by enrolling as many PPCM survivors as possible using both direct and web-based methods of recritment. Patients will anser a questionnaire regarding the onset, progression, treatment and follow-up of their diagnosis as well as the psychosocial aspects of PPCM.

Detailed Description

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The design of our study will utilize web-based recruitment methods with internet-based support groups for PPCM e.g. www.AMothersHeart.org (www.amothersheart.org/index.html). The directors of these websites will facilitate contact between our research staff and the several hundred members of these web sites.

An introductory letter will be posted on the website introducing the cardiovascular research team and describing the purpose, basic methods, and goals of our study. Website members who desire to participate can respond to a dedicated e-mail address we have set up and provide contact information so that we may get informed consent via telephone or mailed written consent. A telephone number will also be provided for participants so that they may call with questions regarding the study. Patients will then receive a questionnaire addressing our study goals. Questions will focus on obtaining family and social history, characterizing presenting symptoms, initial management, and clinical course following delivery of the fetus including extent of cardiovascular follow-up, date of echocardiograms performed, medications, and psychosocial support, if provided.

Conditions

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Cardiomyopathy Pregnancy-Associated Cardiomyopathy Heart Failure

Keywords

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heart failure peripartum cardiomyopathy pregnancy-associated cardiomyopathy pregnancy complications nonischemic cardiomyopathy

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

Patients will be eligible for inclusion if diagnosed with PPCM after January 1, 1994. Patients must be above the age of 18 years old with no prior cardiac history and no history of chronic drug or alcohol abuse. Diagnosis of PPCM must have been made prior after the 28th week of gestation and up to 6 months postpartum. Patients must have echocardiographic data confirming left ventricular systolic dysfunction by either depressed shortening fraction or depressed ejection fraction.

Exclusion Criteria

Patients with an identifiable etiology for their heart failure will be excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Vincent's Medical Center

UNKNOWN

Sponsor Role lead

Principal Investigators

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Jordan G Safirstein, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Vincent's Catholic MEdical Center

Cezar Staniloae, MD, FACC

Role: STUDY_DIRECTOR

SVCMC

Locations

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Saint Vincent's Catholic Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jordan G Safirstein, MD

Role: CONTACT

Phone: 212 604-2228

Email: [email protected]

Facility Contacts

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Eileen Hermance, RN

Role: primary

References

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Ro A, Frishman WH. Peripartum cardiomyopathy. Cardiol Rev. 2006 Jan-Feb;14(1):35-42. doi: 10.1097/01.crd.0000174805.68081.f7.

Reference Type BACKGROUND
PMID: 16371764 (View on PubMed)

Fett JD, Christie LG, Carraway RD, Murphy JG. Five-year prospective study of the incidence and prognosis of peripartum cardiomyopathy at a single institution. Mayo Clin Proc. 2005 Dec;80(12):1602-6. doi: 10.4065/80.12.1602.

Reference Type BACKGROUND
PMID: 16342653 (View on PubMed)

Other Identifiers

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STVincentH

Identifier Type: -

Identifier Source: org_study_id