Investigation in Pregnancy Associate Cardiomyopathy - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	National Institutes of Health (NIH)
Information provided by (Responsible Party):	Jessica E. Pisarcik, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01085955

Purpose

Peri-partum cardiomyopathy is a heart muscle weakness that occurs during or following pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy and other unknown causes, can lead to a process of inflammation of the heart muscle which can weaken the heart and cause cardiomyopathy. Why this process occurs in women during pregnancy is not well understood and if it differs from those women who develop cardiomyopathy from a virus is unknown. This study has been proposed to look at genetic information (DNA) as well as the immune system (the body's response to fight off infections and/or viruses) to find possible causes for the heart muscle damage that occurs in peripartum cardiomyopathy.

Condition
Cardiomyopathy Pregnancy

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Immune Activation and Myocardial Recovery in Peripartum Cardiomyopathy

Resource links provided by NLM:

MedlinePlus related topics: Cardiomyopathy

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Evaluate systemic immune activation as the etiology of PPCM [ Time Frame: 6-12 months ] [ Designated as safety issue: No ]
determine the degree of immune activation in PPCM and the relationship of autoimmunity to left ventricular dysfunction and time course of myocardial recovery, in 100 women enrolled at multiple centers.

Secondary Outcome Measures:

Investigate frequency of myocardial injury or inflammation on cardiac MRI and the ability of tissue characteristics to predict subsequent recovery of LVEF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Cardiac MRI with gadolinium enhancement will be performed in 50 subjects with PPCM from Aim 1 at presentation and repeated at 6 months post partum. We will test the hypothes that subjects with more extensive injury (defined as % myocardium with late gadolinium enhancement) will have less recovery at 6 months

Biospecimen Retention: Samples With DNA

Specimens for cellular analysis, complete blood count, DNA banking and genotyping, RNA analysis and banking, serum banking and for mediator analysis.

Estimated Enrollment:	100
Study Start Date:	October 2009
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Acute Peripartum pregnant women who have recently given birth and diagnosed with peripartum cardiomyopathy
Healthy Peripartum Healthy pregnant women who have recently given birth, used as controls
Healthy, non-pregnant women Healthy non-pregnant women without cardiac disease, used as controls

Detailed Description:

Specific Aim 1: Evaluate systemic immune activation as the etiology of PPCM. We will determine a) the degree of immune activation in PPCM and b) the relationship of autoimmunity to left ventricular dysfunction and time course of myocardial recovery, in 100 women enrolled at 30 centers. Subjects will have blood drawn for assessment of autoantibodies, and cellular immune activation at presentation, 2 month and 6 month postpartum, and will have assessment of LVEF by transthoracic echo at presentation, 2 months, 6 months and 12 months post partum. This aim will explore the hypothesis that more prolonged activation of the cellular and/or humoral immune system is associated with greater likelihood of persistent chronic cardiomyopathy.

In addition this aim will determine genetic and clinical predictors of LV recovery, and evaluate racial differences in presentation, remodeling and recovery. This study will evaluate the echo parameters of dysynchrony, diastolic function, LV size and volumes to determine echo predictors of subsequent recovery. In addition racial differences in presentation, remodeling and recovery will be investigated.

Specific Aim 2: Investigate frequency of myocardial injury or inflammation on cardiac MRI and the ability of tissue characteristics to predict subsequent recovery of LVEF. Cardiac MRI with gadolinium enhancement will be performed in 50 subjects with PPCM from Aim 1 at presentation and repeated at 6 months post partum. We will test the hypothesis is that subjects with more extensive injury (defined as % myocardium with late gadolinium enhancement) will have less recovery at 6 months.

Specific Aim 3: Establish DNA and serum to facilitate future investigations of the pathogenesis of peripartum cardiomyopathy. All subjects enrolled will have DNA, RNA from peripheral blood and serum banked at entry. Serum will be repeated at 2 and 6 months post partum.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

100 women diagnosed with peripartum cardiomyopathy

Criteria

Inclusion Criteria:

Patient of 16 years of age or older
Diagnosis of peripartum cardiomyopathy
Presentation for enrollment no earlier than one month pre-term and no later than two months post partum.
LVEF less than OR equal to 0.45 by echocardiogram

Additional inclusion criteria for MRI substudy:

Must be post partum
Participant is not breast feeding or is willing to forego breast feeding for 24 hours post gadolinium.

Exclusion Criteria:

Previous diagnosis of cardiomyopathy, valvular disease or complex congenital heart disease
Evidence of CAD (>50% stenosis of major epicardial vessel or positive non-invasive stress test)
Previous cardiac transplant
Chemotherapy or chest radiation within 5 years of enrollment
Evidence of ongoing bacterial septicemia (positive blood cultures)
Medical, social, or psychiatric condition which limit the ability to comply with follow-up (Example: alcohol or drug abuse)

Additional Exclusion for MRI Substudy

GFR < 30mL/1.7 m2 by MDRD equation (http://www.kidney.org/professionals/kdogi/gfr_calculator.cfm)
Currently breast feeding or unwilling to forego for 24 hour period post gadolinium
Implanted devices (cochlear implants, pacemakers, defibrillators, infusion pumps, nerve stimulators, etc)
Cerebral aneurysm clips
Swan Ganz catheter or intra aortic balloon pump
Ocular metal or metallic splinters in the eye
Pregnant women
Metal shrapnel or bullet
Allergy to Gadolinium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085955

Contacts

Contact: Jessica Pisarcik, RN BSN

412-647-4463

pisarcikje2@upmc.edu

Show 30 Study Locations

Sponsors and Collaborators

University of Pittsburgh

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Dennis McNamara, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	Jessica E. Pisarcik, Prinicipal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT01085955 History of Changes
Other Study ID Numbers:	IPAC
Study First Received:	March 10, 2010
Last Updated:	March 27, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

peripartum
cardiomyopathy
post pregnancy
myocardial recovery
pregnant women with peripartum cardiomyopathy

Additional relevant MeSH terms:

Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012