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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Active Comparator | Participants receive standard clinical evaluation and management in primary care without NT-proBNP testing and without point-of-care ultrasound (POCUS). |
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| Standard of care + NT-proBNP | Active Comparator | Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing, but without point-of-care ultrasound (POCUS). |
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| Standard of care + NT-proBNP + POCUS | Experimental | Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing and cardiac point-of-care ultrasound (POCUS). |
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| Standard of care + POCUS | Experimental | Participants receive standard clinical evaluation and management in primary care with cardiac point-of-care ultrasound (POCUS), but without NT-proBNP testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-proBNP testing | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| New Heart Failure Diagnosis | Proportion of participants with a new diagnosis of heart failure established during follow-up based on clinical evaluation and diagnostic testing according to routine practice. | From baseline to 12 months |
| Initiation of Guideline-Directed Medical Therapy (GDMT) | Proportion of participants in whom guideline-directed medical therapy for heart failure is initiated during follow-up. | From baseline to 12 months |
| Change in Health-Related Quality of Life (KCCQ-12) | Change from baseline in health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) score. | From baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of diagnostic strategies | Evaluation of the cost-effectiveness of diagnostic strategies incorporating NT-proBNP testing and/or point-of-care ultrasound (POCUS), including direct healthcare costs (e.g., diagnostic testing and referrals) and indirect costs (e.g., patient time and productivity loss). | From baseline to 12 months |
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Inclusion Criteria:
Adults aged ≥50 years
Suspected heart failure (based on signs and/or symptoms) OR
Presence of at least two cardiovascular risk factors, including:
Ability to provide written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan dos Santos, MD. | Contact | jonathan.santos@ua.pt |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan dos Santos | Aveiro University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Saúde Familiar Conde da Lousã | Not yet recruiting | Amadora | Portugal |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Cardiac Point-of-Care Ultrasound (POCUS) | Device | 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. |
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| standard of care | Other | Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study. |
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| Quality of Cardiac POCUS Examinations | Assessment of the quality and interpretability of cardiac point-of-care ultrasound (POCUS) examinations performed by trained primary care physicians, based on expert review. | From baseline to 12 months |
| Healthcare Resource Utilization | Assessment of healthcare resource utilization, including the number of conventional echocardiograms performed and referrals to specialist care. | From baseline to 12 months |
| Unidade de Saúde Familiar do Parque | Not yet recruiting | Lisbon | Portugal |
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| Unidade de Saúde Familiar Rodrigues Miguéis | Not yet recruiting | Lisbon | Portugal |
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| Unidade de Saúde Familiar Garcia Orta | Recruiting | Porto | Portugal |
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