Heart Failure Clinical Trials

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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 49
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Portugal
Unidade de Saúde Familiar Conde da Lousã
NOT_YET_RECRUITING
Amadora
Unidade de Saúde Familiar do Parque
NOT_YET_RECRUITING
Lisbon
Unidade de Saúde Familiar Rodrigues Miguéis
NOT_YET_RECRUITING
Lisbon
Unidade de Saúde Familiar Garcia Orta
RECRUITING
Porto
Contact Information
Primary
Jonathan dos Santos, MD.
jonathan.santos@ua.pt
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2027-07
Participants
Target number of participants: 160
Treatments
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).
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).
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).
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.
Related Therapeutic Areas
Sponsors
Leads: Universidade do Porto

This content was sourced from clinicaltrials.gov