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。
研究者
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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