Determination of the Prevalence of Unrecognized Heart Failure Among Patients at Risk in Urban Areas Across Germany Using CMR

Официальное название

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

Обзор

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 ( \> 1.000.000 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).

Подробное описание

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, 600 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 (\> 1.000.000 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 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.

Первичные конечные точки

• Prevalence of asymptomatic pre-heart failure (stage B) in an urban population [Срок оценки: at baseline]

Вторичные конечные точки (2)

• Prevalence of chronic kidney disease (CKD) [Срок оценки: at baseline]
• Adherence to therapy [Срок оценки: 1, 5 years and 10 years later]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Германия · 1 центр

• Deutsches Herzzentrum der Charité — Berlin

Публикации

• Peters AE, Clare RM, Chiswell K, Felker GM, Kelsey A, Mentz R, DeVore AD. Echocardiographic Features Beyond Ejection Fraction and Associated Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction. Circ Heart Fail. 2023 May;16(5):e010252. doi: 10.1161/CIRCHEARTFAILURE.122.010252. Epub 2023 May 16. PMID 37192287
• Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Preve PMID 23616602
• Young KA, Scott CG, Rodeheffer RJ, Chen HH. Progression of Preclinical Heart Failure: A Description of Stage A and B Heart Failure in a Community Population. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007216. doi: 10.1161/CIRCOUTCOMES.120.007216. Epub 2021 May 6. PMID 33951931
• Unverzagt S, Meyer G, Mittmann S, Samos FA, Unverzagt M, Prondzinsky R. Improving Treatment Adherence in Heart Failure. Dtsch Arztebl Int. 2016 Jun 24;113(25):423-30. doi: 10.3238/arztebl.2016.0423. PMID 27397013
• Witt UE, Muller ML, Beyer RE, Wieditz J, Salem S, Hashemi D, Chen W, Cvetkovic M, Nolden AC, Doeblin P, Blum M, Thiede G, Huppertz A, Steen H, Remppis BA, Falk V, Friede T, Kelle S. A simplified approach to discriminate between healthy subjects and patients with heart failure using cardiac magnetic resonance myocardial deformation imaging. Eur Heart J Imaging Methods Pract. 2024 Sep 12;2(3):qyae09 PMID 39318449
• Young KA, Scott CG, Rodeheffer RJ, Chen HH. Incidence of Preclinical Heart Failure in a Community Population. J Am Heart Assoc. 2022 Aug 2;11(15):e025519. doi: 10.1161/JAHA.122.025519. Epub 2022 Jul 20. PMID 35862175
• NVL Chronische Herzinsuffizienz Langfassung - Version 4.0, 2023
• Spertus JA, Jones PG, Sandhu AT, Arnold SV. Interpreting the Kansas City Cardiomyopathy Questionnaire in Clinical Trials and Clinical Care: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Nov 17;76(20):2379-2390. doi: 10.1016/j.jacc.2020.09.542. PMID 33183512

Идентификаторы

NCT: NCT07185100 · WE-CARE-HF-CMR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗