Heart FailurePRIMARY-HFNCT07711821
PRIMARY-HF: Heart Failure Screening in Primary Care Using Point-of- Care
A study testing NT-proBNP testing and Cardiac Point-of-Care Ultrasound (POCUS) in people with Heart Failure, run by Universidade do Porto at 4 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 49 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- NT-proBNP testing and Cardiac Point-of-Care Ultrasound (POCUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesPortugal
- Study dates
- 23 Mar 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jonathan dos Santos, MD. contact
Portugal4 sites, 4 recruiting
- Not yet recruiting
Unidade de Saúde Familiar Conde da Lousã
Amadora
Miguel Henriques, 914 338 519 ext. (+351), miguelcachinho@gmail.com
- Not yet recruiting
Unidade de Saúde Familiar do Parque
Lisbon
Joana Gonçalves, 961 703 789 ext. (+351), joana.goncalves@ulssm.min-saude.pt
- Not yet recruiting
Unidade de Saúde Familiar Rodrigues Miguéis
Lisbon
Inês Santos, 911 178 033 ext. (+351), inessalmeidasantos@gmail.com
- Recruiting
Unidade de Saúde Familiar Garcia Orta
Porto
Rita Queirós, 917 257 162 ext. (+351), queiros.rita.ana@gmail.com
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Heart Failure
- Being tested
- NT-proBNP testing, Cardiac Point-of-Care Ultrasound (POCUS), standard of care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNP testingDiagnostic test
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)Device
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 careOther
Usual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Participants receive standard clinical evaluation and management in primary care without NT-proBNP testing and without point-of-care ultrasound (POCUS). Receives: Other: standard of care |
| Standard of care + NT-proBNP | Active comparator | Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing, but without point-of-care ultrasound (POCUS). Receives: Diagnostic Test: NT-proBNP testing; Other: standard of care |
| Standard of care + NT-proBNP + POCUS | Experimental | Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing and cardiac point-of-care ultrasound (POCUS). Receives: Diagnostic Test: NT-proBNP testing; Device: Cardiac Point-of-Care Ultrasound (POCUS); Other: standard of care |
| Standard of care + POCUS | Experimental | Participants receive standard clinical evaluation and management in primary care with cardiac point-of-care ultrasound (POCUS), but without NT-proBNP testing. Receives: Device: Cardiac Point-of-Care Ultrasound (POCUS); Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 months
Initiation of Guideline-Directed Medical Therapy (GDMT)
Proportion of participants in whom guideline-directed medical therapy for heart failure is initiated during follow-up.
Measured: From baseline to 12 months
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.
Measured: From baseline to 12 months
Secondary outcomes (3)
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).
Measured: From baseline to 12 months
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.
Measured: From baseline to 12 months
Healthcare Resource Utilization
Assessment of healthcare resource utilization, including the number of conventional echocardiograms performed and referrals to specialist care.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start23 Mar 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan dos Santos, Principal investigator, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711821
- Sponsor's protocol ID
- PRIMARY-HF
- Acronym
- PRIMARY-HF
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMARY-HF: Diagnóstico de Insuficiência Cardíaca em Cuidados de Saúde Primários Utilizando Ecografia Point-of-Care e Péptidos Natriuréticos
- ClinicalTrials.gov ID
- NCT07711821
- Acronym / sponsor ID
- PRIMARY-HF / PRIMARY-HF
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: standard of careParticipants receive standard clinical evaluation and management in primary care without NT-proBNP testing and without point-of-care ultrasound (POCUS). |
| Standard of care + NT-proBNP | Active comparator | Diagnostic Test: NT-proBNP testing, Other: standard of careParticipants receive standard clinical evaluation and management in primary care with NT-proBNP testing, but without point-of-care ultrasound (POCUS). |
| Standard of care + NT-proBNP + POCUS | Experimental | Diagnostic Test: NT-proBNP testing, Device: Cardiac Point-of-Care Ultrasound (POCUS), Other: standard of careParticipants receive standard clinical evaluation and management in primary care with NT-proBNP testing and cardiac point-of-care ultrasound (POCUS). |
| Standard of care + POCUS | Experimental | Device: Cardiac Point-of-Care Ultrasound (POCUS), Other: standard of careParticipants receive standard clinical evaluation and management in primary care with cardiac point-of-care ultrasound (POCUS), but without NT-proBNP testing. |
Who may qualify
- Ages
- 49 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged ≥50 years
- Suspected heart failure (based on signs and/or symptoms) OR
- Presence of at least two cardiovascular risk factors, including:
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-proBNP testingMeasurement 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. | Diagnostic test | Standard of care + NT-proBNP, Standard of care + NT-proBNP + POCUS |
| 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. | Device | Standard of care + NT-proBNP + POCUS, Standard of care + POCUS |
| standard of careUsual clinical evaluation and management in primary care according to standard practice, without additional diagnostic interventions specified in the study. | Other | Standard of care, Standard of care + NT-proBNP, Standard of care + NT-proBNP + POCUS, Standard of care + POCUS |
Primary outcome
New Heart Failure Diagnosis
Time frame: 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)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan dos Santos, MD. contact
Jonathan dos Santos principal investigator
Aveiro University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NT-proBNP testing and Cardiac Point-of-Care Ultrasound (POCUS) in people with Heart Failure, run by Universidade do Porto at 4 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan dos Santos, MD. (jonathan.santos@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Heart Failure Diagnosis (time frame: From baseline to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.