Peripartum Cardiomyopathy Clinical Trial
— PPCMREGISTRYOfficial title:
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
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 19, 2026 |
Est. primary completion date | February 19, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. Exclusion Criteria - Presence of any identifiable cause of HF; - Presence of recognizable heart disease before the last month of pregnancy. |
Country | Name | City | State |
---|---|---|---|
Italy | Federico II University Hospital | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University | San Giuseppe Moscati Hospital, San Raffaele University Hospital, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death or hospitalization due to heart failure | Death or hospitalization due to heart failure during the follow-up period | 0-6 months | |
Primary | Development of significant cardiac arrhythmias | New onset sustained supraventricular or ventricular arrhythmias or conduction blocks during the follow-up period | 0-6 months | |
Secondary | Left ventricular dysfunction | Left ventricular % ejection fraction during the follow-up period | 0-6 months |
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