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Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05878041
Acronym
PPCMREGISTRY
Enrollment
40
Registered
2023-05-26
Start date
2024-02-21
Completion date
2026-05-19
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripartum Cardiomyopathy

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.

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.

Interventions

DIAGNOSTIC_TESTMolecular and genetic screening

Molecular and genetic screening

Sponsors

San Raffaele University Hospital, Italy
CollaboratorOTHER
San Giuseppe Moscati Hospital
CollaboratorOTHER
Federico II University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Death or hospitalization due to heart failure0-6 monthsDeath or hospitalization due to heart failure during the follow-up period
Development of significant cardiac arrhythmias0-6 monthsNew onset sustained supraventricular or ventricular arrhythmias or conduction blocks during the follow-up period

Secondary

MeasureTime frameDescription
Left ventricular dysfunction0-6 monthsLeft ventricular % ejection fraction during the follow-up period

Countries

Italy

Contacts

Primary ContactCinzia Perrino
perrino@unina.it+39 081 7462223

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026