PPCM Observational Study (Peripartum Cardiomyopathy)

NCT04234659 | Completed

• 1 other identifier: PRO35709
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the clinical treatment of patients diagnosed with peripartum cardiomyopathy complicated by cardiogenic shock.

Conditions

Peripartum Cardiomyopathy; Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

• Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock.

  The retrospective and prospective data collected from study participants will report clinical treatments required to treat the diagnosis of peripartum cardiomyopathy complicated by cardiogenic shock.

  From onset of event through 90 days after participant enrollment.

Study Arms (2)

Individuals Receiving Mechanical Circulatory Device Support

Individuals receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.

Device: Clinical placement of a temporary IMPELLA® mechanical circulatory support device.

Individuals Without Mechanical Circulatory Device Support

Individuals not receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.

Interventions

Clinical placement of a temporary IMPELLA® mechanical circulatory support device. DEVICE

Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.

Individuals Receiving Mechanical Circulatory Device Support

Eligibility Criteria

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

Study Population

Females meeting study eligibility criteria who have been diagnosed and treated clinically for peripartum cardiomyopathy complicated by cardiogenic shock. A total of 10 participants will be enrolled in each of the two study cohorts (groups).

You may qualify if:

• Females:
• age ≥ 18 years old at the time of entry into the study
• who have capacity to provide consent for study participation
• with self-reported PPCM complicated by cardiogenic shock
• individuals should have US citizenship
• index event occurring within the continental United States.

You may not qualify if:

• lack of medical records supporting pregnancy, peripartum cardiomyopathy or cardiogenic shock by study definition
• inability of participant to provide informed consent

Sponsors & Collaborators

• Abiomed Inc.: collaborator
• University of Pennsylvania: collaborator
• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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 BACKGROUND

• Kolte D, Khera S, Aronow WS, Palaniswamy C, Mujib M, Ahn C, Jain D, Gass A, Ahmed A, Panza JA, Fonarow GC. Temporal trends in incidence and outcomes of peripartum cardiomyopathy in the United States: a nationwide population-based study. J Am Heart Assoc. 2014 Jun 4;3(3):e001056. doi: 10.1161/JAHA.114.001056.

  PMID: 24901108 BACKGROUND

• Doerr M, Grayson S, Moore S, Suver C, Wilbanks J, Wagner J. Implementing a universal informed consent process for the All of Us Research Program. Pac Symp Biocomput. 2019;24:427-438.

  PMID: 30963079 BACKGROUND

MeSH Terms

Conditions

Peripartum Cardiomyopathy; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Pregnancy Complications, Cardiovascular; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Sarah Thordsen, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: January 21, 2020
• Study Start: January 11, 2021
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)