PPCM Observational Study (Peripartum Cardiomyopathy)

• Conditions: Peripartum Cardiomyopathy; Cardiogenic Shock
• Interventions: Device: Clinical placement of a temporary IMPELLA® mechanical circulatory support device.

• Registration Number: NCT04234659
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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

Detailed Description

This single-site, virtual, longitudinal, observational study will investigate two cohorts (study groups) by enrolling a total of ten participants, five in each cohort. The two cohorts include individuals who received mechanical circulatory support (specifically the IMPELLA® device) compared to individuals who did not receive mechanical circulatory support for treatment of their PPCM complicated by cardiogenic shock index event.

The duration of enrollment for each participant is about 5 months. It is anticipated that the trial will be complete in 12 months. Participant engagement to the study will be self-initiated.

Under the guidance and support of Medical College of Wisconsin research coordinator, participants will directly access the study REDCapTM database for enrollment and follow-up data entry for this study. The research coordinator will obtain and abstract participant medical records documenting the event.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-21
• Study Start: 2021-01-11
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-09
• Last Update Posted: 2021-12-13
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals Receiving Mechanical Circulatory Device Support	Clinical placement of a temporary IMPELLA® mechanical circulatory support device.	Individuals receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.

Primary Outcome Measures

Name	Time	Method
Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock.	From onset of event through 90 days after participant enrollment.	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.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States