Investigation in Pregnancy Associate Cardiomyopathy

NCT01085955 | Completed DMC

• 1 other identifier: IPAC
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 30

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.

Conditions

Cardiomyopathy; Pregnancy

Keywords

peripartum; cardiomyopathy; post pregnancy; myocardial recovery; pregnant women with peripartum cardiomyopathy

Outcome Measures

Primary Outcomes (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.

  6-12 months

Secondary Outcomes (1)

• Investigate frequency of myocardial injury or inflammation on cardiac MRI and the ability of tissue characteristics to predict subsequent recovery of LVEF

  6 months

Other Outcomes (1)

• Long Term Survival Data

  up to 5 years

Study Arms (4)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 women diagnosed with peripartum cardiomyopathy

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator

Study Sites (30)

University of Southern California

Los Angeles, California, 90033-1026, United States

Location

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Louisiana State University Health Science Center

Louisiana, Louisiana, 71130, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General

Boston, Massachusetts, 02114-2696, United States

Location

Brigham and Women's

Boston, Massachusetts, 02115, United States

Location

DMC Cardiovascular Institute / Harper University Hospital

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Gagnon Cardiovascular Institute at Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-8167, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157-1045, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15237, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas, Southwestern

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Sir Mortimer B. Davis / Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (3)

• 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.

  PMID: 28373243 DERIVED

• 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.

  PMID: 26970832 DERIVED

• 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.

  PMID: 26293760 DERIVED

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.

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dennis McNamara, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 12, 2010
• Study Start: October 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

CA (2); US (28)