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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05878041
Other study ID # PNRR-MR1-2022-12376858
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 21, 2024
Est. completion date May 19, 2026

Study information

Verified date March 2024
Source Federico II University
Contact Cinzia Perrino
Phone +39 081 7462223
Email perrino@unina.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Molecular and genetic screening
Molecular and genetic screening

Locations

Country Name City State
Italy Federico II University Hospital Naples

Sponsors (3)

Lead Sponsor Collaborator
Federico II University San Giuseppe Moscati Hospital, San Raffaele University Hospital, Italy

Country where clinical trial is conducted

Italy, 

Outcome

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
See also
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Recruiting NCT04927715 - Irisin Expression and Gene Polymorphism With Peripartum Cardiomyopathy.