跳至主要内容
临床试验/NCT05878041
NCT05878041招募中不适用

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

Federico II University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Development of significant cardiac arrhythmias

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Development of significant cardiac arrhythmias

时间窗: 0-6 months

New onset sustained supraventricular or ventricular arrhythmias or conduction blocks during the follow-up period

Death or hospitalization due to heart failure

时间窗: 0-6 months

Death or hospitalization due to heart failure during the follow-up period

次要结局

  • Left ventricular dysfunction(0-6 months)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cinzia Perrino

Associate Professor of Cardiology

Federico II University

研究点 (1)

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