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Идёт набор NCT07731490

Early Detection and IntervenTion in Heart Failure

Без фазы С лечением Heart Failure (HF)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis..
Кому может быть актуально
Состояния в реестре: Heart Failure (HF). Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австрия, Болгария, Германия, Италия, Нидерланды +4
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Heart failure (HF) occurs when the heart is no longer able to pump blood effectively throughout the body. This leads to symptoms that gradually worsen over time and are often mistaken for normal signs of aging. Because of its insidious onset, early detection is challenging. Both patients and healthcare professionals are often insufficiently aware of the early signs and symptoms of HF, resulting in delayed diagnosis. Consequently, timely initiation of treatments that could slow disease progression, improve quality of life, and reduce hospitalizations is often missed. Although a simple blood test measuring NT-proBNP levels can facilitate the early diagnosis of HF, it is not routinely used in clinical practice. The aim of this study is to evaluate whether a combined strategy for the early diagnosis and treatment of HF can reduce hospitalizations. This strategy includes: 1. increasing awareness of HF among patients and physicians, 2. using NT-proBNP testing for the early detection of HF in high-risk patients, and 3. promptly initiating guideline-directed HF treatment when the diagnosis is confirmed. The researchers will assess whether this strategy effectively reduces hospitalizations due to acute heart failure over an 18-month follow-up period.

Подробное описание

Heart failure (HF) is a significant global health issue, affecting approximately 64 million individuals worldwide and resulting in over a million hospitalizations annually in Europe and the US. This imposes substantial healthcare costs exceeding $100 billion yearly, with about 70% attributed to acute hospitalizations. The aging population contributes to a rising burden, as HF is often diagnosed late, even in well-funded healthcare settings. Recent insights from studies, including the ongoing BASEL VIII study, challenge the assumption that undetected HF is primarily a failure to detect HF in primary care, revealing a high prevalence of undetected HF even among patients treated by cardiologists. This research initiative revealed that among patients ≥ 65 years, only 3% had known HF, while 29% had undetected HF. Similar observations were also noted in various high-risk settings worldwide, suggesting a surprisingly high rate of undetected HF in clinical practice. Late diagnosis is driven by gradual symptom development, non-specific symptoms often attributed to aging, insensitive clinical signs, and inadequate utilization of B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) testing, the recommended tools for HF diagnosis. The misconception that HF competes with other cardiac diagnoses, rather than complementing them, further contributes to delayed diagnosis. Emerging evidence supports a strategy combining increased awareness, active surveillance using NT-proBNP testing for early HF diagnosis, and prompt treatment with approved evidence-based therapies to reduce HF hospitalizations. However, such intervention bundles are not systematically applied, as no randomized controlled trial (RCT) has ever investigated the efficacy of such structured interventions on hard outcomes. This research initiative aims to assess the effectiveness of an intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis. The study aims to fill critical gaps and evaluate patient-centred outcomes, including hospitalization for acute HF, and health economic implications by using routine clinical data and the standard operating procedures as part of routine clinical practice in the participating sites. By addressing these challenges, the initiative seeks to enhance patient outcomes, reduce the burden on healthcare systems, and contribute to advancing HF care. The bundle intervention, comprising an educational program, guidelines-directed diagnostics, and guidelines-supported management, represents a proactive implementation of best clinical practice. As this proactive approach is not routinely implemented in real-world clinical dynamics, this study primarily focuses on accompanying the implementation of the intervention bundle and contributing valuable data regarding its efficacy. At the same time, the intervention is expected to offer a number of potential benefits for the patients, their health care providers, and the society in general. This will be achieved by a better understanding of the HF problem among patients and medical staff, better adherence to guidelines-supported best clinical practices, and the potential avoidance of hospitalisations due to acute HF.

Вмешательства

  • Другое Intervention bundle comprising increased awareness, early diagnostics, and early treatment to improve HF prognosis.
    The study aims to fill critical gaps and evaluate patient-centred outcomes, including hospitalization for acute HF, and health economic implications by using routine clinical data and the standard operating procedures as part of routine clinical practice in the participating sites.

Первичные конечные точки

  • Acute HF event [Срок оценки: 18 months after intervention]
Вторичные конечные точки (9)
  • CV death or acute HF event [Срок оценки: 18 months]
  • Hierarchical ordinal composite of CV death, acute HF hospitalization, acute HF during index hospitalization, and no event [Срок оценки: 18 months]
  • All-cause death [Срок оценки: 18 months]
  • Cardiovascular death [Срок оценки: 18 months]
  • All-cause hospitalizations [Срок оценки: 18 months]
  • Changes in medical treatment between the index hospitalisation [Срок оценки: 18 months]
  • Change in kidney function [Срок оценки: 18 months]
  • Health economic outcomes: cost of patient management [Срок оценки: 18 months]
  • Health economic outcome: cost-effectiveness in terms of cost per hospitalization for acute HF avoided [Срок оценки: 18 months]

Критерии участия

Критерии включения

  • General consent (GC) has not been rejected.
  • Age ≥ 65 years.
  • Elective percutaneous coronary intervention\* (PCI), pulmonary vein isolation\* (PVI), pacemaker implantation\* (PM, no cardiac resynchronisation), transcatheter aortic valve intervention\* (TAVI), major non-cardiac surgery\* or presenting with tachyarrhythmia to the emergency department (ED) (without a diagnosis of HF within 24h).
  • Exclusion criteria are assessed on day 1 after the procedure

Критерии исключения

  • Systolic blood pressure ≤ 95 mmHg
  • Estimated glomerular filtration rate (GFR) <30 mL/min/1.73 m2.
  • Dementia documented in the medical history.
  • Metastatic cancer in the medical history.
  • Previously enrolled in this study.
  • Known HF.
  • Known allergies, hypersensitivity, or intolerance to SGLT2 Inhibitors / Loop Diuretics / MRA or is excipients.
  • Non-resident in the country of the recruiting site
  • Incapacity of the patient to make judgements
  • Patients not hospitalized overnight
  • Patients requiring intensive care unit (ICU) or intermediate care (IMC) stay beyond 11:00 a.m. on the first postoperative day or any post-interventional stroke unit stay until 8:00 a.m. on the first postoperative day.
  • Patients died prior to postinterventional day 1 (8:00 a.m.)
  • Severe aortic or mitral stenosis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Диагностика

Центры проведения

Швейцария · 11 центров
  • University Hospital Basel — Basel
  • University Hospital Lausanne — Lausanne
  • KSA Kantonsspital Aarau — Aarau
  • Cantonal Hospital Baden — Baden
  • St. Claraspital AG — Basel
  • University Hospital Genève — Geneva
  • Kantonsspital Luzern — Lucerne
  • Hospital Istituto Cardiocentro Ticino — Lugano
  • … и ещё 3 центра
Германия · 3 центра
  • University Hospital Freiburg-Bad Krozingen — Freiburg im Breisgau
  • Universitätsklinikum der Ruhr-Universität Bochum — Herne
  • Herzzentrum Leipzig, Klinik für Innere Medizin/Kardiologie — Leipzig
Австрия · 1 центр
  • Universitätsklinik für Innere Medizin II — Vienna
Болгария · 1 центр
  • Queen Giovanna University Hospital — Sofia
Италия · 1 центр
  • University Hospital Pisa — Pisa
Нидерланды · 1 центр
  • Erasmus MC Rotterdam — Rotterdam
South Korea · 1 центр
  • Konkuk University Medical Center — Seoul
Испания · 1 центр
  • University Hospital Ramón y Cajal Madrid — Madrid
Великобритания · 1 центр
  • Royal Infirmary Edinburgh — Edinburgh

Идентификаторы

NCT: NCT07731490 · 2024-02339

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗