Investigation in Pregnancy Associate Cardiomyopathy (IPAC)
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| ClinicalTrials.gov Identifier: NCT01085955 |
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Recruitment Status :
Completed
First Posted : March 12, 2010
Last Update Posted : January 15, 2016
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| Condition or disease |
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| Cardiomyopathy Pregnancy |
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 |
| Actual Enrollment : | 100 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Immune Activation and Myocardial Recovery in Peripartum Cardiomyopathy |
| Study Start Date : | October 2009 |
| Actual Primary Completion Date : | August 2014 |
| Actual Study Completion Date : | August 2014 |
| Group/Cohort |
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Acute Peripartum
pregnant women who have recently given birth and diagnosed with peripartum cardiomyopathy
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Healthy Peripartum
Healthy pregnant women who have recently given birth, used as controls
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Healthy, non-pregnant women
Healthy non-pregnant women without cardiac disease, used as controls
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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.
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- 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.
- 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
- 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)
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085955
Show 30 study locations
| Principal Investigator: | Dennis McNamara, MD | University of Pittsburgh Medical Center |
| Responsible Party: | Dennis McNamara, Prinicipal Investigator, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01085955 |
| Other Study ID Numbers: |
IPAC |
| First Posted: | March 12, 2010 Key Record Dates |
| Last Update Posted: | January 15, 2016 |
| Last Verified: | January 2016 |
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peripartum cardiomyopathy post pregnancy myocardial recovery pregnant women with peripartum cardiomyopathy |
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Cardiomyopathies Heart Diseases Cardiovascular Diseases |