DIAGNOSTIC_TEST
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.
PRIMARY-HF: Heart Failure Screening in Primary Care Using Point-of- Care
Status
Recruiting
Phase
Not applicable
Enrollment
160
Locations
4
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DEVICE
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.
OTHER
standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Timeline
From registration to results.
First posted
Jul 17, 2026
Study start
Mar 23, 2026
Primary completion
Jul 2027
Study completion
Jul 2027
Results posted
Not reported
Registry updated
Jul 17, 2026
Outcomes
What the study measures.
Primary outcomes
New Heart Failure Diagnosis
Time frame · 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)
Time frame · 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)
Time frame · 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 outcomes
Cost-effectiveness of diagnostic strategies
Time frame · 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
Time frame · 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
Time frame · From baseline to 12 months
Assessment of healthcare resource utilization, including the number of conventional echocardiograms performed and referrals to specialist care.
Eligibility
Who can take part.
- Minimum age
- 49 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
4 registered sites.
Portugal. Showing up to 24 locations stored in the fast local snapshot.
Unidade de Saúde Familiar Conde da Lousã
Amadora, Portugal
Unidade de Saúde Familiar do Parque
Lisbon, Portugal
Unidade de Saúde Familiar Rodrigues Miguéis
Lisbon, Portugal
Unidade de Saúde Familiar Garcia Orta
Porto, Portugal
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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