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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• New Heart Failure Diagnosis [Time frame: From baseline to 12 months]
• Initiation of Guideline-Directed Medical Therapy (GDMT) [Time frame: From baseline to 12 months]
• Change in Health-Related Quality of Life (KCCQ-12) [Time frame: From baseline to 12 months]

Secondary outcome measures (3)

• Cost-effectiveness of diagnostic strategies [Time frame: From baseline to 12 months]
• Quality of Cardiac POCUS Examinations [Time frame: From baseline to 12 months]
• Healthcare Resource Utilization [Time frame: From baseline to 12 months]

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:

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Portugal · 4 centers

• Unidade de Saúde Familiar Conde da Lousã — Amadora
• Unidade de Saúde Familiar do Parque — Lisbon
• Unidade de Saúde Familiar Rodrigues Miguéis — Lisbon
• Unidade de Saúde Familiar Garcia Orta — Porto

Identifiers

NCT: NCT07711821 · PRIMARY-HF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗