Идёт набор NCT07711821

PRIMARY-HF: Heart Failure Screening in Primary Care Using Point-of- Care

Без фазы С лечением Heart Failure

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: NT-proBNP testing, Cardiac Point-of-Care Ultrasound (POCUS), standard of care.
Кому может быть актуально: Состояния в реестре: Heart Failure. Базовые параметры: от 49 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: Португалия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

PRIMARY-HF: Diagnóstico de Insuficiência Cardíaca em Cuidados de Saúde Primários Utilizando Ecografia Point-of-Care e Péptidos Natriuréticos

Обзор

The goal of this clinical trial is to evaluate whether the use of NT-proBNP testing and point-of-care ultrasound (POCUS) can improve the diagnosis and management of heart failure in adults aged 50 years or older with suspected heart failure or cardiovascular risk factors in primary care settings. The main questions it aims to answer are: * Does the use of NT-proBNP and/or POCUS increase the rate of new heart failure diagnoses compared with standard care? * Does this approach support earlier initiation of guideline-directed medical therapy and improve patients' quality of life? Researchers will compare standard care alone with standard care combined with NT-proBNP testing, POCUS, or both, to assess their impact on diagnosis and management of heart failure. Participants will: * Be randomly assigned to one of four groups (standard care, NT-proBNP, POCUS, or both). * Undergo clinical evaluation for heart failure according to their assigned group. * Be followed for 12 months with periodic assessments of quality of life and treatment adherence.

Вмешательства

Диагностический тест NT-proBNP testing
Measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in blood as part of the diagnostic evaluation for suspected heart failure in primary care.
Устройство Cardiac Point-of-Care Ultrasound (POCUS)
Cardiac point-of-care ultrasound performed by trained primary care physicians to assess cardiac structure and function as part of the diagnostic evaluation for suspected heart failure.
Другое standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.

Первичные конечные точки

New Heart Failure Diagnosis [Срок оценки: From baseline to 12 months]
Initiation of Guideline-Directed Medical Therapy (GDMT) [Срок оценки: From baseline to 12 months]
Change in Health-Related Quality of Life (KCCQ-12) [Срок оценки: From baseline to 12 months]

Вторичные конечные точки (3)

Cost-effectiveness of diagnostic strategies [Срок оценки: From baseline to 12 months]
Quality of Cardiac POCUS Examinations [Срок оценки: From baseline to 12 months]
Healthcare Resource Utilization [Срок оценки: From baseline to 12 months]

Критерии участия

Критерии включения

Adults aged ≥50 years
Suspected heart failure (based on signs and/or symptoms) OR
Presence of at least two cardiovascular risk factors, including:

Diabetes mellitus
Arterial hypertension
Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²
Albuminuria
Coronary artery disease or prior myocardial infarction or coronary revascularization
Stroke or transient ischemic attack
Atrial fibrillation or flutter
Left ventricular hypertrophy or Q waves on electrocardiogram
Obesity (body mass index ≥30 kg/m²)
Ability to provide written informed consent