Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.

NCT05878041 | Recruiting

• 1 other identifier: PNRR-MR1-2022-12376858
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripartum Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Left ventricular dysfunction

  0-6 months

Study Arms (2)

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

Healthy pregnant volunteers

Healthy pregnant women

Diagnostic Test: Molecular and genetic screening

Interventions

Molecular and genetic screening DIAGNOSTIC_TEST

Molecular and genetic screening

Healthy pregnant volunteers; Peripartum cardiomyopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Presence of any identifiable cause of HF;
• Presence of recognizable heart disease before the last month of pregnancy.

Sponsors & Collaborators

• Federico II University: lead
• San Raffaele University Hospital, Italy: collaborator
• San Giuseppe Moscati Hospital: collaborator

Study Sites (1)

Federico II University Hospital

Naples, 80131, Italy

RECRUITING

Related Publications (1)

• Ilardi F, Manzo R, Peretto G, Lanni F, Peano V, Loffredo FS, Masarone D, Gerardi D, di Maio S, Bardi L, Licciardi M, Montali N, Pezzullo E, Di Lorenzo E, Stabile E, Battaglia C, Calanducci M, Bifulco G, Anastasia L, Carusone F, Cascone A, Di Santo M, Cavoretto PI, D'Alconzo D, Palmentieri A, Carotenuto M, Di Spiezio Sardo A, Ioele D, Paolillo R, Polese P, Saccone G, Esposito G, Chieffo A, Perrino C. Clinical presentation and echocardiographic characteristics of women with peripartum cardiomyopathy: Insights from the Italian Multicentre Registry. Int J Cardiol. 2026 Jan 1;442:133866. doi: 10.1016/j.ijcard.2025.133866. Epub 2025 Sep 4.

  PMID: 40914510 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells (PBMCs) and serum will be profiled by whole exome sequencing (PBMCs), and proteomics, metabolomics or transcriptomics assays serum.

MeSH Terms

Conditions

Peripartum Cardiomyopathy

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Pregnancy Complications, Cardiovascular; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Cinzia Perrino, MD pHD

  Federico II University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Perrino

CONTACT

+39 081 7462223; perrino@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: February 21, 2024
• Primary Completion: February 19, 2025
• Study Completion (Estimated): May 19, 2026
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)