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

13. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Portugal
      • Amadora, Portugal
        • Ikke rekrutterer endnu
        • Unidade de Saúde Familiar Conde da Lousã
        • Kontakt:
      • Lisbon, Portugal
      • Lisbon, Portugal
        • Ikke rekrutterer endnu
        • Unidade de Saúde Familiar Rodrigues Miguéis
        • Kontakt:
      • Porto, Portugal
        • Rekruttering
        • Unidade de Saúde Familiar Garcia Orta
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard of care
Participants receive standard clinical evaluation and management in primary care without NT-proBNP testing and without point-of-care ultrasound (POCUS).
Andet: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Aktiv komparator: 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).
Andet: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Diagnostisk 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.
Eksperimentel: 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).
Andet: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Diagnostisk 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.
Enhed: 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.
Eksperimentel: 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.
Andet: standard of care
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
New Heart Failure Diagnosis
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cost-effectiveness of diagnostic strategies
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidade do Porto

Efterforskere

  • Ledende efterforsker: Jonathan dos Santos, Aveiro University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. marts 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PRIMARY-HF

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