Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.

Study Overview
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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. We 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.

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.

Official Title
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Creation of a Multicenter National Registry for Peripartum Cardiomyopathy: a Wide, Multidisciplinary and Translational Perspective to Achieve Personalized Medicine for a Rare Disease in Women

Conditions
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Peripartum Cardiomyopathy

Intervention / Treatment
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* Diagnostic Test: Molecular and genetic screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) development of HF signs or symptoms in the last month of pregnancy or within 5 months of delivery; 2) left ventricle systolic dysfunction demonstrated by classical echocardiographic criteria (LVEF< 45 %) in the last month of pregnancy or within 5 months of delivery. - Exclusion Criteria: 1) presence of any identifiable cause of HF; 2) presence of recognizable heart disease before the last month of pregnancy. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Peripartum cardiomyopathy<br>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. | Diagnostic Test: Molecular and genetic screening<br>* Molecular and genetic screening<br>|
| Healthy pregnant volunteers<br>Healthy pregnant women | Diagnostic Test: Molecular and genetic screening<br>* Molecular and genetic screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or hospitalization due to heart failure | Death or hospitalization due to heart failure during the follow-up period | 0-6 months | 
| Development of significant cardiac arrhythmias | New onset sustained supraventricular or ventricular arrhythmias or conduction blocks during the follow-up period | 0-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular dysfunction | Left ventricular % ejection fraction during the follow-up period | 0-6 months |