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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

Study 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.

Eligibility

Primary outcome measure(s)

• New Heart Failure Diagnosis — 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.
• Initiation of Guideline-Directed Medical Therapy (GDMT) — From baseline to 12 months
  Proportion of participants in whom guideline-directed medical therapy for heart failure is initiated during follow-up.
• Change in Health-Related Quality of Life (KCCQ-12) — 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.

Trial sites (4)

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