Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-21

Study Completion Date

2026-05-19

Brief Summary

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Peripartum cardiomyopathy (PPCM) is a rare, severe and potentially life-threatening disorder of largely unknown etiology and pathophysiology, with unexplained geographical differences and heterogeneous presentation. Investigators hypothesize that a network-based multidisciplinary strategy integrating clinical and molecular phenotyping of PPCM patients might anticipate diagnosis, optimize treatments, and identify novel mechanisms to achieve the unmet goal of personalized medicine.

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Detailed Description

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Specific aims of this study are: a) to create a multicenter pilot registry of PPCM in different areas in Italy to assess incidence and prevalence of this rare disease, associated comorbidities and risk factors. b) to deeply characterize identified PPCM patients through clinical, imaging, genetic, biochemical, and molecular phenotyping. c) to gain novel mechanistic information on PPCM by performing deep clinical and molecular phenotyping in available biobanks samples of patients with PPCM and healthy controls.

Conditions

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Peripartum Cardiomyopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Peripartum cardiomyopathy

Diagnosis of Peripartum cardiomyopathy (PPCM) will be defined according to the ESC guidelines as: (i) the development of the disease in the last month of pregnancy or within 5 months of delivery; (i) absence of an identifiable cause of heart failure; (iii) absence of recognizable heart disease before the last month of pregnancy; (iv) left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria.

Molecular and genetic screening

Intervention Type DIAGNOSTIC_TEST

Molecular and genetic screening

Healthy pregnant volunteers

Healthy pregnant women

Molecular and genetic screening

Intervention Type DIAGNOSTIC_TEST

Molecular and genetic screening

Interventions

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Molecular and genetic screening

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Development of HF signs or symptoms in the last month of pregnancy or within 5 months of delivery;
* Left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria (LVEF\< 45 %) in the last month of pregnancy or within 5 months of delivery.