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

ClinicalTrials.gov ID

NCT07711821

Lead Sponsor

Universidade do PortoOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

160Estimated

Last Update Posted

Jul 17, 2026Actual

Start Date

Mar 23, 2026Actual

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

Official Title

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

Brief 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.

• Heart Failure

• NT-proBNP testing
• Cardiac Point-of-Care Ultrasound (POCUS)
• standard of care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Universidade do PortoOTHER

joana.goncalves@ulssm.min-saude.pt961 703 789 ext. (+351)

queiros.rita.ana@gmail.com917 257 162 ext. (+351)

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