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

Federico II University

Status: Enrolling

Conditions: Peripartum Cardiomyopathy

Treatments: Diagnostic Test: Molecular and genetic screening

Study type: Observational

Funder types: Other

Identifiers

NCT05878041

PNRR-MR1-2022-12376858

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

40 participants in 2 patient groups

Peripartum cardiomyopathy

Description:

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.

Treatment:

Diagnostic Test: Molecular and genetic screening

Healthy pregnant volunteers

Description:

Healthy pregnant women

Treatment:

Diagnostic Test: Molecular and genetic screening