Registry and Survey of Women With Pregnancy Related Cardiomyopathy

Heart Failure Clinical Trial

Official title:

Pregnancy Related Cardiomyopathy Enrollment and Lessons in Web-Based Recruitment (PRiCELESS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00273637
• Other study ID #: STVincentH
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2006
• Last updated: May 25, 2006
• Start date: October 2005
• Est. completion date: January 2006

Study information

• Verified date: October 2005
• Source: St. Vincent's Medical Center
• Contact: Jordan G Safirstein, MD
• Phone: 212 604-2228
• Email: priceless[@]svcmcny.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure
• Pregnancy-Associated Cardiomyopathy

Locations

Country	Name	City	State
United States	Saint Vincent's Catholic Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Vincent's Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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

External Links

•   Website support group intimately involved in the enrollment and education of our study participants