Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.

Last updated: March 20, 2024
Sponsor: Federico II University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Circulation Disorders

Cardiomyopathy

Treatment

Molecular and genetic screening

Clinical Study ID

NCT05878041
PNRR-MR1-2022-12376858
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Molecular and genetic screening
Phase:
Study Start date:
February 21, 2024
Estimated Completion Date:
May 19, 2026

Study 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.

Connect with a study center

  • Federico II University Hospital

    Naples, 80131
    Italy

    Active - Recruiting

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