Heart Failure
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTNT-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.
DEVICECardiac 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.
OTHERstandard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Sponsors
Universidade do Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
49 Years to No maximum
Healthy volunteers
No
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: 1. Diabetes mellitus 2. Arterial hypertension 3. Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m² 4. Albuminuria 5. Coronary artery disease or prior myocardial infarction or coronary revascularization 6. Stroke or transient ischemic attack 7. Atrial fibrillation or flutter 8. Left ventricular hypertrophy or Q waves on electrocardiogram 9. Obesity (body mass index ≥30 kg/m²) * Ability to provide written informed consent
Exclusion criteria
* Known heart failure under active hospital-based follow-up * Terminal illness or life expectancy \<1 year * Severe comorbid conditions limiting participation or follow-up * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Heart Failure Diagnosis | From baseline to 12 months | 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. |
| Initiation of Guideline-Directed Medical Therapy (GDMT) | From baseline to 12 months | Proportion of participants in whom guideline-directed medical therapy for heart failure is initiated during follow-up. |
| Change in Health-Related Quality of Life (KCCQ-12) | From baseline to 12 months | Change from baseline in health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of diagnostic strategies | From baseline to 12 months | 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). |
| Quality of Cardiac POCUS Examinations | From baseline to 12 months | Assessment of the quality and interpretability of cardiac point-of-care ultrasound (POCUS) examinations performed by trained primary care physicians, based on expert review. |
| Healthcare Resource Utilization | From baseline to 12 months | Assessment of healthcare resource utilization, including the number of conventional echocardiograms performed and referrals to specialist care. |
Countries
Portugal
Contacts
CONTACTJonathan dos Santos, MD.
PRINCIPAL_INVESTIGATORJonathan dos Santos
Aveiro University
Outcome results
None listed