Investigation in Pregnancy Associate Cardiomyopathy (IPAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dennis McNamara, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01085955
First received: March 10, 2010
Last updated: March 1, 2013
Last verified: March 2013
  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:


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


Other Outcome Measures:
  • Long Term Survival Data [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    We are asking women to extend thier consent for 5 additional years from thier delivery date to collect survival data (alive, transplanted, VAD implanted; medications; NYAH Class; subsequent pregnancies)


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
New Non-ischemic CMP
Women 18-60 years old who have been diagnosed with non-ishemic cardiomyopathy within the last 6 months and have an ejection fraction less than OR equal to 45% by echocardiogram.

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
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: NCT01085955

  Show 30 Study Locations
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dennis McNamara, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dennis McNamara, 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 1, 2013
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 July 10, 2014