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NCT Number: NCT07711821

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

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

49 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidade de Saúde Familiar Conde da Lousã, Amadora, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. 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).

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan dos Santos, MD.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

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

Acronym: PRIMARY-HF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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