Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.

Recruiting

• Conditions: Peripartum Cardiomyopathy
• Interventions: Diagnostic Test: Molecular and genetic screening

• Registration Number: NCT05878041
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-26
• Study Start: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-02-19
• Study Completion: 2026-05-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy pregnant volunteers	Molecular and genetic screening	Healthy pregnant women
Peripartum cardiomyopathy	Molecular and genetic screening	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Left ventricular dysfunction	0-6 months	Left ventricular % ejection fraction during the follow-up period

Trial Locations

Locations (1)

Federico II University Hospital; 🇮🇹 Naples, Italy