Creating a 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
This study is creating a national registry to better understand peripartum cardiomyopathy by tracking its occurrence and related health issues in new mothers across Italy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT05878041 on ClinicalTrials.gov |
What this trial studies
This study aims to establish a multicenter national registry for peripartum cardiomyopathy (PPCM) across various locations in Italy. It will assess the incidence and prevalence of PPCM, along with associated comorbidities and risk factors. The study will involve detailed clinical, imaging, genetic, biochemical, and molecular phenotyping of identified PPCM patients to enhance understanding of the condition. Additionally, it seeks to uncover novel mechanisms related to PPCM using samples from biobanks of affected patients and healthy controls.
Who should consider this trial
Good fit: Ideal candidates for this study are women who develop heart failure signs or symptoms during the last month of pregnancy or within five months after delivery.
Not a fit: Patients with identifiable causes of heart failure or pre-existing heart disease before the last month of pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and personalized treatment strategies for patients with peripartum cardiomyopathy.
How similar studies have performed: While there is limited data on similar multicenter registries for PPCM, the approach of integrating clinical and molecular phenotyping has shown promise in other cardiovascular conditions.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Naples
- Federico II University Hospital — Naples, Italy (Recruiting)
Study contacts
- Principal investigator: Cinzia Perrino, MD pHD — Federico II University
- Study coordinator: Cinzia Perrino
- Email: perrino@unina.it
- Phone: +39 081 7462223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.