Clinical trial NCT04234659: PPCM Observational Study (Peripartum Cardiomyopathy)
Official title: Observational Study for Outcomes for Participants With Cardiogenic Shock and Peripartum Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripartum Cardiomyopathy
Cardiogenic Shock
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Abiomed Inc.
name: University of Pennsylvania
First posted: 2020-01-21
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock.
timeFrame: From onset of event through 90 days after participant enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Sarah Thordsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.