跳至主要内容
临床试验/ISRCTN17189947
ISRCTN17189947
进行中(未招募)
未知

An observational study to correlate IMMUNE cell biology with Dilated CardioMyopathy patient characteristics (IMMUNE-DCM)

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 100 人2024年5月2日

概览

阶段
未知
干预措施
未指定
疾病 / 适应症
Heart failure
发起方
ewcastle upon Tyne Hospitals NHS Foundation Trust
入组人数
100
状态
进行中(未招募)
最后更新
去年

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2024年5月2日
结束日期
2025年12月31日
最后更新
去年
研究类型
Observational
性别
All

研究者

发起方
ewcastle upon Tyne Hospitals NHS Foundation Trust

入排标准

入选标准

  • 1\. Established diagnosis of non\-ischemic (dilated) cardiomyopathy, who have been receiving guideline\-directed standard of care (SoC) pharmacological treatment for at least 3 months.
  • 2\. Diagnosis according to ESC guidelines: left ventricular or biventricular systolic dysfunction and dilatation that are not explained by abnormal loading conditions or coronary artery disease. Specifically \- Systolic dysfunction defined by abnormal LV ejection fraction, measured using any modality and shown either by two independent imaging modalities or on two distinct occasions by the same technique, preferably echocardiography or CMR.
  • 3\. Ability to adhere to study requirements including provision of consent to genetic testing
  • 4\. Aged \> \= 18 years

排除标准

  • 1\. Heart failure due to either congenital heart disease, hypertensive heart disease, primary valvular heart disease, active acute myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy or a known correctable metabolic cause;
  • 2\. Active vasculitis
  • 3\. Known cognitive impairment or unable to provide consent.
  • 4\. Serious co\-existing medical condition, including but not limited to known hepatic failure, known renal failure with known eGFR \< 30 mL/min/1\.73m², or severe psychiatric disorder, known at the time of inclusion.
  • 5\. Cardiogenic shock, non\-compensated acute heart failure and/or pulmonary oedema.
  • 6\. Cardiac resynchronization pacemaker implantation within previous 3 months.
  • 7\. Active infection at the time of enrolment.
  • 8\. History of established coronary disease with known epicardial stenosis of more than 70%
  • 9\. Patients unable to tolerate or undergo MRI scanning including patients with claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants unless approved for use in MRI scanners or excessive body weight (BMI\> 45 kg/m²)
  • 10\. Known allergy to gadolinium contrast.

结局指标

主要结局

未指定

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