Creation of a Multicenter National Registry for Peripartum Cardiomyopathy. (PPCMREGISTRY)

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.

Study Overview

• Status: Recruiting
• Conditions: Peripartum Cardiomyopathy
• Intervention / Treatment: Diagnostic test: Molecular and genetic screening

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Cinzia Perrino; Phone Number: +39 081 7462223; Email: perrino@unina.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Federico II University Hospital
    • Contact: Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of 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 (Eur Heart J 2018;34: 3165; Eur Heart J 2021; 42: 3599). Like other rare diseases, correct diagnosis of PPCM is mostly based on exclusion criteria; however, the differential diagnosis between PPCM, pre-existing chronic heart failure, and other causes of acute heart failure in the peripartum scenario remains challenging.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peripartum cardiomyopathy; 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; Molecular and genetic screening
Healthy pregnant volunteers; Healthy pregnant women	Diagnostic test: Molecular and genetic screening; Molecular and genetic screening

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University
• Collaborators: San Raffaele University Hospital, Italy; San Giuseppe Moscati Hospital
• Investigators: Principal Investigator: Cinzia Perrino, MD pHD, Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): February 19, 2025
• Study Completion (Estimated): May 19, 2026

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: PNRR-MR1-2022-12376858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No