AzTrials
AzTrials

CardiomyopathyIPACNCT01085955

Investigation in Pregnancy Associate Cardiomyopathy

An observational study of Cardiomyopathy and Pregnancy, run by University of Pittsburgh at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Cardiomyopathy, Pregnancy
How many people
100 participants
Where
30 sitesin 2 countries
Study dates
Oct 2009to Aug 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 100 women diagnosed with peripartum cardiomyopathy

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 16Show fewer
  • 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

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

United States28 sites

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Massachusetts General

    Boston, Massachusetts, 02114-2696

  • Brigham and Women's

    Boston, Massachusetts, 02115

  • University of Illinois

    Chicago, Illinois, 60612

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas, Southwestern

    Dallas, Texas, 75235

  • DMC Cardiovascular Institute / Harper University Hospital

    Detroit, Michigan, 48201

  • Duke University

    Durham, North Carolina, 27705

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of Southern California

    Los Angeles, California, 90033-1026

  • Louisiana State University Health Science Center

    Louisiana, Louisiana, 71130

  • University of Miami, Miller School of Medicine

    Miami, Florida, 33136

  • Gagnon Cardiovascular Institute at Morristown Memorial Hospital

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Columbia University

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15237

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107

  • Washington University

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794-8167

  • Wake Forest University

    Winston-Salem, North Carolina, 27157-1045

Other trials in United States

Canada2 sites

  • Foothills Medical Center

    Calgary, Alberta, T2N 2T9

  • Sir Mortimer B. Davis / Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

Official title: Immune Activation and Myocardial Recovery in Peripartum Cardiomyopathy

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.

Read the 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.

Keywords
peripartum, cardiomyopathy, post pregnancy, myocardial recovery, pregnant women with peripartum cardiomyopathy
Medical subject headings
Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01085955
Study groupRoleWhat they receive
Acute Peripartumpregnant women who have recently given birth and diagnosed with peripartum cardiomyopathy
Healthy PeripartumHealthy pregnant women who have recently given birth, used as controls
Healthy, non-pregnant womenHealthy non-pregnant women without cardiac disease, used as controls
New Non-ischemic CMPWomen 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate systemic immune activation as the etiology of PPCM

    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.

    Measured: 6-12 months

Secondary outcomes (1)

  1. 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 hypothes that subjects with more extensive injury (defined as % myocardium with late gadolinium enhancement) will have less recovery at 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01085955
Sponsor's protocol ID
IPAC
Acronym
IPAC
Status last verified
Jan 2016
First submitted
10 Mar 2010
Last updated
15 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Schelbert EB, Elkayam U, Cooper LT, Givertz MM, Alexis JD, Briller J, Felker GM, Chaparro S, Kealey A, Pisarcik J, Fett JD, McNamara DM; Investigations of Pregnancy Associated Cardiomyopathy (IPAC) Investigators. Myocardial Damage Detected by Late Gadolinium Enhancement Cardiac Magnetic Resonance Is Uncommon in Peripartum Cardiomyopathy. J Am Heart Assoc. 2017 Apr 3;6(4):e005472. doi: 10.1161/JAHA.117.005472.

    PubMed 28373243

  • Damp J, Givertz MM, Semigran M, Alharethi R, Ewald G, Felker GM, Bozkurt B, Boehmer J, Haythe J, Skopicki H, Hanley-Yanez K, Pisarcik J, Halder I, Gorcsan J 3rd, Rana S, Arany Z, Fett JD, McNamara DM; IPAC Investigators. Relaxin-2 and Soluble Flt1 Levels in Peripartum Cardiomyopathy: Results of the Multicenter IPAC Study. JACC Heart Fail. 2016 May;4(5):380-8. doi: 10.1016/j.jchf.2016.01.004. Epub 2016 Mar 9.

    PubMed 26970832

  • McNamara DM, Elkayam U, Alharethi R, Damp J, Hsich E, Ewald G, Modi K, Alexis JD, Ramani GV, Semigran MJ, Haythe J, Markham DW, Marek J, Gorcsan J 3rd, Wu WC, Lin Y, Halder I, Pisarcik J, Cooper LT, Fett JD; IPAC Investigators. Clinical Outcomes for Peripartum Cardiomyopathy in North America: Results of the IPAC Study (Investigations of Pregnancy-Associated Cardiomyopathy). J Am Coll Cardiol. 2015 Aug 25;66(8):905-14. doi: 10.1016/j.jacc.2015.06.1309.

    PubMed 26293760

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiomyopathy and Pregnancy, run by University of Pittsburgh at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate systemic immune activation as the etiology of PPCM (time frame: 6-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01085955, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in