ClinicalTrials.gg
RecruitingNCT07711821PRIMARY-HFUpdated Jul 17, 2026

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

An interventional study of NT-proBNP testing and Cardiac Point-of-Care Ultrasound (POCUS) in Heart Failure, sponsored by Universidade do Porto. Recruiting at 4 sites in Portugal. Open to participants aged 49 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by Universidade do Porto · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2026, registered Jul 2026).
  • Started Mar 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
49 Years and older
Sex
All
01

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.
02

Conditions studied

  • Heart Failure

Browse trials for

03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 160 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Universidade do Porto is the lead sponsor of 174 studies on the registry; 53 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
49 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (eGFR) \<60 mL/min/1.73 m²
    4. Albuminuria
    5. Coronary artery disease or prior myocardial infarction or coronary revascularization
    6. Stroke or
    7. Atrial fibrillation or flutter
    8. Left ventricular hypertrophy or Q waves on
    9. Obesity ( ≥30 kg/m²)
  • Ability to provide written

Exclusion criteria

Exclusion Criteria:

  • Known heart failure under active hospital-based follow-up
  • Terminal illness or \<1 year
  • Severe comorbid conditions limiting participation or follow-up
  • Inability to provide
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    Standard of care

    Participants receive standard clinical evaluation and management in primary care without NT-proBNP testing and without point-of-care ultrasound (POCUS).

    Other: standard of care

  • Active comparator
    Standard of care + NT-proBNP

    Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing, but without point-of-care ultrasound (POCUS).

    Diagnostic Test: NT-proBNP testing · Other: standard of care

  • Experimental
    Standard of care + NT-proBNP + POCUS

    Participants receive standard clinical evaluation and management in primary care with NT-proBNP testing and cardiac point-of-care ultrasound (POCUS).

    Diagnostic Test: NT-proBNP testing · Device: Cardiac Point-of-Care Ultrasound (POCUS) · Other: standard of care

  • Experimental
    Standard of care + POCUS

    Participants receive standard clinical evaluation and management in primary care with cardiac point-of-care ultrasound (POCUS), but without NT-proBNP testing.

    Device: Cardiac Point-of-Care Ultrasound (POCUS) · Other: standard of care

Interventions

  • Diagnostic testNT-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.

  • DeviceCardiac 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.

  • Otherstandard of care

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

06

What researchers measure

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 months

  2. 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 months

  3. 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 months

Secondary 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 months

  2. 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 months

  3. 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 months

07

Study locations

1 of 4 sites recruiting
  • Unidade de Saúde Familiar Conde da Lousã
    Amadora, Portugal
    Not yet recruiting
  • Unidade de Saúde Familiar do Parque
    Lisbon, Portugal
    Not yet recruiting
  • Unidade de Saúde Familiar Rodrigues Miguéis
    Lisbon, Portugal
    Not yet recruiting
  • Unidade de Saúde Familiar Garcia Orta
    Porto, Portugal
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07711821
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Mar 23, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jul 17, 2026

Study contacts

Jonathan dos Santos, MD.
Contact
jonathan.santos@ua.pt
Jonathan dos Santos
principal investigator · Aveiro University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion