Registry and Survey of Women With Pregnancy Related Cardiomyopathy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2005 by St. Vincent's Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

St. Vincent's Medical Center

ClinicalTrials.gov Identifier:

NCT00273637

First received: January 5, 2006

Last updated: May 25, 2006

Last verified: October 2005

History of Changes

Purpose

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.

Condition
Cardiomyopathy Pregnancy-Associated Cardiomyopathy Heart Failure


Study Type:	Observational
Study Design:	Observational Model: Defined Population Time Perspective: Cross-Sectional
Official Title:	Pregnancy Related Cardiomyopathy Enrollment and Lessons in Web-Based Recruitment (PRiCELESS)

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy Heart Failure

Genetic and Rare Diseases Information Center resources: Peripartum Cardiomyopathy

U.S. FDA Resources

Further study details as provided by St. Vincent's Medical Center:


Estimated Enrollment:	175
Study Start Date:	October 2005
Estimated Study Completion Date:	January 2006

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273637

Contacts


Contact: Jordan G Safirstein, MD	212 604-2228	priceless@svcmcny.org

Locations


United States, New York
Saint Vincent's Catholic Medical Center	Recruiting
New York, New York, United States, 10011
Contact: Eileen Hermance, RN 212-604-2228 ehermance@svcmcny.org
Principal Investigator: Jordan G Safirsteinn, MD
Sub-Investigator: Joonun Choi, MD
Sub-Investigator: Angela Ro, MD
Sub-Investigator: Sree Grandhi, MD
Sub-Investigator: Eileen Hermance, RN
Sub-Investigator: Cezar Staniloae, MD< FACC

Sponsors and Collaborators

St. Vincent's Medical Center

Investigators


Principal Investigator:	Jordan G Safirstein, MD	Saint Vincent's Catholic MEdical Center
Study Director:	Cezar Staniloae, MD, FACC	SVCMC

More Information

Additional Information:

Website support group intimately involved in the enrollment and education of our study participants This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Ro A, Frishman WH. Peripartum cardiomyopathy. Cardiol Rev. 2006 Jan-Feb;14(1):35-42. Review.

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.


ClinicalTrials.gov Identifier:	NCT00273637 History of Changes
Other Study ID Numbers:	STVincentH
Study First Received:	January 5, 2006
Last Updated:	May 25, 2006
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Vincent's Medical Center:


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

Additional relevant MeSH terms:


Cardiomyopathies Heart Failure Cardiovascular Diseases Heart Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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