Clinical trial NCT05878041: Creation of a Multicenter National Registry for Peripartum Cardiomyopathy.
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripartum Cardiomyopathy
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: San Raffaele University Hospital, Italy
name: San Giuseppe Moscati Hospital
First posted: 2023-05-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Death or hospitalization due to heart failure
timeFrame: 0-6 months
measure: Development of significant cardiac arrhythmias
timeFrame: 0-6 months
Secondary outcomes:
measure: Left ventricular dysfunction
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University Hospital
Study officials:
affiliation: Federico II University
name: Cinzia Perrino, MD pHD
role: PRINCIPAL_INVESTIGATOR
References: