PRIMARY-HF: Heart Failure Screening in Primary Care Using Point-of- Care
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age49+
SponsorUniversidade do Porto
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged ≥50 years
Suspected heart failure (based on signs and/or symptoms) OR
Diabetes mellitus
Arterial hypertension
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
NT-proBNP testing
Diagnostic testMeasurement 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)
DeviceCardiac 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
Other interventionUsual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: Standard of careActive comparator 1 intervention
Group B: Standard of care + NT-proBNPActive comparator 2 interventions
Group C: Standard of care + NT-proBNP + POCUSExperimental treatment 3 interventions
Group D: Standard of care + POCUSExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
New Heart Failure Diagnosis
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.
Time frame
From baseline to 12 months2
Initiation of Guideline-Directed Medical Therapy (GDMT)
Proportion of participants in whom guideline-directed medical therapy for heart failure is initiated during follow-up.
Time frame
From baseline to 12 months3
Change in Health-Related Quality of Life (KCCQ-12)
Change from baseline in health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ-12) score.
Time frame
From baseline to 12 monthsSecondary outcomes
1
Cost-effectiveness of diagnostic strategies
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).
Time frame
From baseline to 12 months2
Quality of Cardiac POCUS Examinations
Assessment of the quality and interpretability of cardiac point-of-care ultrasound (POCUS) examinations performed by trained primary care physicians, based on expert review.
Time frame
From baseline to 12 months3
Healthcare Resource Utilization
Assessment of healthcare resource utilization, including the number of conventional echocardiograms performed and referrals to specialist care.
Time frame
From baseline to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov