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Investigation in Pregnancy Associate Cardiomyopathy (IPAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085955
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : January 15, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Dennis McNamara, University of Pittsburgh

Tracking Information
First Submitted Date March 10, 2010
First Posted Date March 12, 2010
Last Update Posted Date January 15, 2016
Study Start Date October 2009
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2010)
Evaluate systemic immune activation as the etiology of PPCM [ Time Frame: 6-12 months ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 10, 2010)
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 ]
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 1, 2013)
Long Term Survival Data [ Time Frame: up to 5 years ]
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)
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation in Pregnancy Associate Cardiomyopathy
Official Title Immune Activation and Myocardial Recovery in Peripartum Cardiomyopathy
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Specimens for cellular analysis, complete blood count, DNA banking and genotyping, RNA analysis and banking, serum banking and for mediator analysis.
Sampling Method Probability Sample
Study Population 100 women diagnosed with peripartum cardiomyopathy
Condition
  • Cardiomyopathy
  • Pregnancy
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 10, 2010)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01085955
Other Study ID Numbers IPAC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Dennis McNamara, University of Pittsburgh
Original Responsible Party Dennis McNamara, MD, University of Pittsburgh Medical Center
Current Study Sponsor University of Pittsburgh
Original Study Sponsor Same as current
Collaborators National Institutes of Health (NIH)
Investigators
Principal Investigator: Dennis McNamara, MD University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date January 2016