"HerzCheck" - Erkennung Und Prävention Einer Frühen Herzinsuffizienz Mittels Telemedizinischer Verfahren in Strukturschwachen Regionen
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,509
- 试验地点
- 2
- 主要终点
- Improved GLS
研究概览
简要总结
This study is intended to provide a basis for decision-making for the improved medical care of patients with asymptomatic heart failure, especially in structurally weak regions.
详细描述
The aim of the study is the early detection of asymptomatic heart failure with a quality-assured cardiac screening MRI in the population in structurally weak regions and especially in patients with risk factors for the occurrence of heart failure. The diagnosis is followed by early initiation of appropriate therapeutic measures to improve the prognosis of the affected patients, avoid hospitalisations and save therapy costs, and is combined with recommended measures to minimise risk factors for the development of heart failure. The project includes a prospective, monocentric, randomised controlled clinical trial with blinded assessment of the endpoint (PROBE design). Within the scope of the study, 4,509 patients aged between 40 and 69 years who have characteristic risk factors for the development of heart failure were examined using a mobile cardiac screening MRI in the federal states of Brandenburg and Mecklenburg-Western Pomerania within Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The attending physician who examines the patients is blinded.
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypercholesterolaemia
- •Arterial hypertension
- •Chronic diabetes mellitus
- •Chronic kidney disease
- •Health insurance
排除标准
- •Previously diagnosed Heart Failure
- •MRI-exclusion criteria
结局指标
主要结局
Improved GLS
时间窗: 12 months
Improved GLS at after one year compared to baseline.
次要结局
- Body weight in kilograms and body height in meters will be aggregated to report BMI in kg/m^2(12 months)
- Systolic and diastolic blood pressure in mmHg(12 months)
- Heart rate in BPM(12 months)
- Quality of life questionnaire 1 in Likert scale(12 months)
- Quality of life questionnaire 2 in Likert scale(12 months)
- laboratory parameters: Iron, transferrin and creatinine(12 months)
- laboratory parameters: Sodium, potassium, chloride, total cholesterol, triglycerides, HDL cholesterole, LDL cholesterole, hemoglobin and MCHC(12 months)
- laboratory parameters: White cells and platelets(12 months)
- laboratory parameters: MCV(12 months)
- laboratory parameters: RDW-SD(12 months)
- laboratory parameter: HbA1c(12 months)
- laboratory parameter: red cells(12 months)
- laboratory parameter: MCH(12 months)
- laboratory parameter: hematocrit(12 months)
- laboratory parameter: NT-proBNP(12 months)
- laboratory parameter: transferrin saturation(12 months)
- laboratory parameter: ferritin(12 months)
- hospitalisations of cardiac origin, arrhythmias or death(12 months)
- Laboratory parameters: urine albumin-creatinine ratio(12 months)
研究者
Sebastian Kelle
Dr. Sebastian Kelle (MD)
German Heart Institute