A Prospective, Cross-sectional, Nationwide Community-based Observational Study to Determine the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Prevalence of asymptomatic pre-heart failure (stage B) in an urban population
研究概览
简要总结
Heart failure (HF) in patients at risk is often overlooked, and when detected, there is a lack of early and effective preventive interventions. The WE-CARE-HF-CMR study, conducted in large cities/metropol areas in Germany ( > 500.000 inhabitants), aims to close this gap by evaluating the feasibility of a mobile, telemedicinemonitored HF-screening approach combining cardiac magnetic resonance imaging (CMR), quality of life assessment and laboratory tests as key elements in asymptomatic patients at risk. WE-CARE-HF-CMR will provide a proposal for a comprehensive, contemporary screening approach for patients at risk to develop HF tailored to the needs of the target population. This will provide important new information on the prevalence of asymptomatic HF in at-risk patients in urban versus rural areas.
The results of the study will be compared with the results from the "HERZCheck'' trial, which provides data from approximately 4,500 participants in rural areas in Germany and has already been completed (NCT05122793).
详细描述
The WE-CARE-HF-CMR-study is a cross-sectional, nationwide prospective, community-based observational study to improve the diagnosis of heart failure in urban populations with characteristic risk factors for the occurrence of heart failure using telemedically-supervised mobile diagnostic units. The central diagnostic methods employed in the assessed screening routine comprise a questionnaire-based medical history, laboratory testing and a standardized, non-invasive imaging examination.
Within the framework of the study, 450 subjects aged 40 to 69 years and of male, female or diverse gender, who have characteristic risk factors for the occurrence of asymptomatic heart failure will be examined.
The central diagnostic imaging method of the study is a standardized, needle- as well as stress- and contrast-agent-free CMR exam. The examinations are carried out in mobile MRI diagnostic units at various clinic locations in 5 major cities (> 500.000 residents) in Germany. The various clinics were recommended as locations because they offer good infrastructural conditions for setting up the mobile MRI diagnostic units, which are 27 t truck units, and because emergency medical care for the study participants can also be guaranteed. The medical staff of the clinics is not involved in the study. The potential study participants will be informed exclusively via telemedicine by the investigators of the DHZC in a video call either in a room rented specifically for this purpose or in an accompanying vehicle of the mobile MRI diagnostic unit. The consent of the study participants is also obtained via telemedicine and in accordance with current legal requirements in Germany. The planned examinations in the mobile diagnostic unit will be carried out exclusively by the staff of the company operating the MRI units on behalf of and under the telemedical supervision of the investigators and the study management of the DHZC, acting as the central unit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Asymptomatic subjects with:
- •chronic diabetes mellitus (known/diagnosed and/or antidiabetic medication and/or elevated HbA1C) and/or
- •renal impairment (known/diagnosed CKD and/or in laboratory CKD III° or higher) and/or
- •Hypertension (known/diagnosed and/or antihypertensive medication/treatment) and/or
- •Hypercholesterolaemia (known/diagnosed and/or antilipid medication/treatment) and/or
- •Obesity (known/diagnosed and/or BMI > 30 (kg/m²)) and/or
- •Smoker (known/diagnosed and/or current/previous and/or medication/treatment)
- •Age 40-69 years
- •female or male or diverse sex
- •Ability to provide informed consent
- •Provision of Informed Consent
排除标准
- •Inability to provide written informed consent
- •Diagnosed heart failure or previously detected reduced ejection fraction
- •General MRI exclusion criteria (pacemaker, defibrillator, intracranial aneurysm clips, metallic foreign bodies in the eyes)
- •Any MRI exclusion criteria not listed here, as determined by the MRI laboratory performing the procedure
- •Haemodynamically unstable participants (heart rate < 45/min, systolic blood pressure < 90 mmHg)
- •Claustrophobia
- •Sensorineural hearing loss of 30 dB or more and tinnitus
- •Acute mental disorders requiring therapy
- •In the presence of pregnancy
结局指标
主要结局
Prevalence of asymptomatic pre-heart failure (stage B) in an urban population
时间窗: at baseline
Asymptomatic pre-heart failure (stage B) is defined as CMR-derived global longitudinal strain (GLS) ≥ -15%
次要结局
- Prevalence of chronic kidney disease (CKD)(at baseline)
- Adherence to therapy(5 years and 10 years later)
研究者
Sebastian Kelle
Dr. Sebastian Kelle (MD)
German Heart Institute