跳至主要内容
临床试验/NCT07131371
NCT07131371进行中(未招募)不适用

Stratification, Management, and Guidance of Hypertrophic Cardiomyopathy Patients Using Hybrid Digital Twin Solutions

Tampere University1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2024年1月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,500
试验地点
1
主要终点
Clinical characteristics of patients with severe arrhythmias, heart failure, sudden death or implantation of ICD for Digital Twin creation

研究概览

简要总结

The goal of SMASH-HCM is to develop a digital twin or virtual model of the heart and vascular system with sympathetic nerve control that integrates multi-scale and multi-organ spatiotemporal biophysical data from a multitude of sources. SMASH-HCM's digital twin powered platform will dramatically improve hypertrophic cardiomyopathy (HCM) patient stratification and disease management through stepwise deep phenotyping integrated in clinical and patient-guided workflows.

详细描述

The aim of this SMASH-HCM study is with available well-characterized clinical data and existing iPSC derived cardiomyocyte data from HCM patients to find better predictors of worse outcomes i.e. potentially lethal arrhythmias, heart failure, sudden cardiac arrest in HCM patients. Additionally with artificial intelligence (AI) to find markers of good outcome so that we could focus more on those who would potentially benefit more from the intense follow up. Additionally our aim is to create a digital twin by collecting all possible clinical data from the HCM patients and also from currently healthy mutation carriers to be able to predicts the clinical out in more personal way and also toddling treatment strategies in more personal manner.

研究设计

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

入排标准

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

入选标准

  • HCM or carrying. mutation for HCM

排除标准

  • 未提供

研究组 & 干预措施

HCM patients from Florence Italy, Rennes, France, and Tampere Finland

HCM patients in follow up

结局指标

主要结局

Clinical characteristics of patients with severe arrhythmias, heart failure, sudden death or implantation of ICD for Digital Twin creation

时间窗: from patient records until the end of 2026

The presence of arrhythmias will be obtained from 24 h Holter recordings, stress exercise test, monitor recording if in the hospital and if found in clinical patient records. Heart failure data if obtained from ultrasound records, clinical observations and elevated natriuretic peptide levels in the serum. Data about sudden deaths are obtained from patient records. Requirements of ICD implantations are obtained from patient records

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katriina Aalto-Setälä

Professor

Tampere University

研究点 (1)

Loading locations...

相似试验

Stratification, Management, and Guidance of... | 临床试验