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临床试验/NCT05989945
NCT05989945进行中(未招募)不适用

HIDRAdenitis Suppurativa and HEART Disease

Herlev and Gentofte Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
250
试验地点
1
主要终点
Coronary revascularization (percutaneous coronary intervention/coronary artery bypass graft)

研究概览

简要总结

In a prospective observational cohort study (n = 250) the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and HS severity and determine whether these are prognostic markers of heart disease in patients suffering from hidradenitis suppurativa (HS).

详细描述

Rationale and background CVD is mainly caused by atherosclerosis, now considered as a chronic inflammatory disease of blood vessels . Likewise, HS is a chronic and relapsing, inflammatory, immune mediated disease. Atherosclerosis and HS therefore share several pathophysiological traits. Previous epidemiological studies have demonstrated increased prevalence of cardiovascular (CV) risk factors in HS patients, including metabolic syndrome, cigarette smoking, obesity, hypertension, diabetes mellitus, insulin resistance and dyslipidemia. Furthermore, studies suggest that HS may be an independent risk factor for cardiovascular disease such as myocardial infarction, coronary artery disease and cardiovascular mortality. In addition, HS might be associated with surrogate markers of cardiovascular disease and increased platelet activity, e.g. endothelial dysfunction and coronary calcification.

The fundamental role of inflammation in cardiovascular disease has prompted interest in the predictive capability of numerous biomarkers such as interleukins, hsCRP, hsTNT and pro-BNP that detect subclinical levels of inflammation. Hence, these inflammatory biomarkers might be able to reveal a pro-inflammatory disease state that represent a significant risk of CVD. Likewise, novel myocardial deformation imaging echocardiography, such as Tissue Doppler Imaging (TDI) and 2-dimensional speckle tracking echocardiography (2DSE), have been able to demonstrate subtle signs of myocardial dysfunction in high risk persons from the general population despite a normal conventional echocardiography. These advanced echocardiographic techniques can detect asymptomatic reduced left ventricular function, which is not visible to the naked eye. Early identification of high risk patients is of utmost importance in order to initiate appropriate treatment and risk factor management in attempt to minimize further left ventricular damage and ensure better quality of life.

Hypothesis Studies suggest that patients with the skin disease Hidradenitis Suppurativa (HS) have an increased risk of developing cardiovascular disease (CVD), including a higher risk of myocardial infarction when compared to the general population. However, the mechanisms behind this are not fully understood, nor is it known how many HS patients have either precursors to - or unrecognized - heart disease. The project group aims to map these mechanisms using echocardiography and measuring biomarkers in the blood of HS patients. Our theory is that a certain amount of HS patients may have signs of early or unrecognized CVD, which can be detected with echocardiography and biomarkers. Therefore, the investigators wish to assess whether echocardiography, ECG and biomarker measurements have a place in the complete evaluation of HS in the future, so that treatment initiatives can be taken in time to delay or perhaps even prevent the development of severe CVD.

Objective:

In a prospective observational cohort study (n = 250) the aim is to investigate the correlation between cardiac biomarkers, advanced echocardiography and HS severity and determine whether these are prognostic markers of heart disease in patients suffering from hidradenitis suppurativa (HS).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age ≥ 18 years
  • Diagnosis of HS

排除标准

  • Patients unable to cooperate to the study and/or study examinations
  • Patients unable to understand and sign informed consent

结局指标

主要结局

Coronary revascularization (percutaneous coronary intervention/coronary artery bypass graft)

时间窗: 2, 5 and 10 year follow-up

Cardiovascular mortality

时间窗: 2, 5 and 10 year follow-up

Myocardial infarction

时间窗: 2, 5 and 10 year follow-up

Heart failure

时间窗: 2, 5 and 10 year follow-up

次要结局

  • All-cause mortality(2, 5 and 10 year follow-up)
  • Stroke(2, 5 and 10 year follow-up)
  • Admission with cardiac heart failure(2, 5 and 10 year follow-up)
  • Admission with stroke(2, 5 and 10 year follow-up)

研究者

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

Maria Flarup Dons

MD, fellow

Herlev and Gentofte Hospital

研究点 (1)

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