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

July 13, 2026 updated by: Universidade do Porto

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Amadora, Portugal
        • Not yet recruiting
        • Unidade de Saúde Familiar Conde da Lousã
        • Contact:
      • Lisbon, Portugal
      • Lisbon, Portugal
        • Not yet recruiting
        • Unidade de Saúde Familiar Rodrigues Miguéis
        • Contact:
      • Porto, Portugal
        • Recruiting
        • Unidade de Saúde Familiar Garcia Orta
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
Participants receive standard clinical evaluation and management in primary care without NT-proBNP testing and without point-of-care ultrasound (POCUS).
Other: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Active Comparator: Standard of care + NT-proBNP
Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing, but without point-of-care ultrasound (POCUS).
Other: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
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.
Experimental: Standard of care + NT-proBNP + POCUS
Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing and cardiac point-of-care ultrasound (POCUS).
Other: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
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.
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.
Experimental: Standard of care + POCUS
Participants receive standard clinical evaluation and management in primary care with cardiac point-of-care ultrasound (POCUS), but without NT-proBNP testing.
Other: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 12 months
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.
From baseline to 12 months
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.
From baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From baseline to 12 months
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.
From baseline to 12 months
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.
From baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Investigators

  • Principal Investigator: Jonathan dos Santos, Aveiro University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIMARY-HF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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