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

NCT07711821 — Not applicable, Recruiting, 160 participants, Universidade do Porto

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

Registry	NCT07711821, acronym PRIMARY-HF
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, diagnostic
Enrollment	160 (Estimated)
Sponsor	Universidade do Porto (Other)
Conditions	Heart Failure
Interventions	NT-proBNP testing, Cardiac Point-of-Care Ultrasound (POCUS), standard of care (Diagnostic test, device, other)
Dates	start 2026-03-23, primary completion 2027-07-01 (estimated), completion 2027-07-01 (estimated), first posted 2026-07-17, last updated 2026-07-17
Locations	4 sites in Portugal

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard of care	Active comparator	Other: standard of care	Participants receive standard clinical evaluation and management in primary care without NT-proBNP testing and without point-of-care ultrasound (POCUS).
Standard of care + NT-proBNP	Active comparator	Diagnostic Test: NT-proBNP testing; Other: standard of care	Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing, but without point-of-care ultrasound (POCUS).
Standard of care + NT-proBNP + POCUS	Experimental	Diagnostic Test: NT-proBNP testing; Device: Cardiac Point-of-Care Ultrasound (POCUS); Other: standard of care	Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing and cardiac point-of-care ultrasound (POCUS).
Standard of care + POCUS	Experimental	Device: Cardiac Point-of-Care Ultrasound (POCUS); Other: standard of care	Participants receive standard clinical evaluation and management in primary care with cardiac point-of-care ultrasound (POCUS), but without NT-proBNP testing.

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.
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.
standard of care (Other): Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 49 Years to any

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

+Locations (4)

Facility	City	Country	Status
Unidade de Saúde Familiar Conde da Lousã	Amadora	Portugal	Not yet recruiting
Unidade de Saúde Familiar do Parque	Lisbon	Portugal	Not yet recruiting
Unidade de Saúde Familiar Rodrigues Miguéis	Lisbon	Portugal	Not yet recruiting
Unidade de Saúde Familiar Garcia Orta	Porto	Portugal	Recruiting

+Investigators

Jonathan dos Santos, Principal investigator, Aveiro University