Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.

Peripartum Cardiomyopathy Clinical Trial

— PPCMREGISTRY  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05878041
• Other study ID #: PNRR-MR1-2022-12376858
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Peripartum Cardiomyopathy

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