PPCM Observational Study (Peripartum Cardiomyopathy)

Cardiogenic Shock Clinical Trial

Official title:

Observational Study for Outcomes for Participants With Cardiogenic Shock and Peripartum Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234659
• Other study ID #: PRO35709
• Status: Recruiting
• Start date: January 11, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2021
• Source: Medical College of Wisconsin
• Contact: Susan K. Mauermann, RN
• Phone: 414-955-6749
• Email: smauerma[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Cardiomyopathies
• Peripartum Cardiomyopathy
• Shock, Cardiogenic

Intervention

Device:
• Clinical placement of a temporary IMPELLA® mechanical circulatory support device.
Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Abiomed Inc., University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.