PORTHOS - PORTuguese Heart Failure Observational Study

AstraZeneca

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05434923

D1699R00015

Details and patient eligibility

About

This study aims to determine the prevalence of heart failure in the resident population in mainland Portugal aged 50 years or above, using a contemporary, guideline-based diagnostic approach, to optimize patient management and improve strategic healthcare decision-making

Full description

The contemporary prevalence of heart failure in Portugal is largely unknown and may differ from that reported in early studies, which were conducted in the late 1990s-early 2000s with the diagnostic techniques available at the time and did not include neither advanced echocardiographic parameters nor natriuretic peptides measurements. Thus, a large and representative study is needed to address knowledge gaps on the epidemiology, characteristics and burden of heart failure in Portugal. The study aims to determine the prevalence of global heart failure, as well as heart failure subtypes. It also aims to assess the distribution of comorbidities among patients with heart failure, as well as patients' health-related quality of life. The Investigators will conduct a population-based study with a three-stage design approach, enrolling 5616 subjects aged 50 years or above, randomly selected through multi-stage sampling, using the National Health Service as reference: PHASE 0 - Participant selection/enrollment through phone call; PHASE 1 - Screening (NT-proBNP levels determination), health-related quality of life evaluation and sociodemographic characterization; PHASE 2 - Confirmatory assessment with a 12-lead electrocardiography, comprehensive transthoracic echocardiography, extended symptoms assessment and biomarkers assessment; PHASE 3 - Heart failure with preserved ejection fraction exertion testing through a non-invasive echocardiographic diastolic stress test.

Enrollment: 6,189 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Community-dwelling citizens living in Mainland Portugal;
• Registration in a primary care centre;
• Age ≥50 years at recruitment;
• Voluntary signed informed consent.

Exclusion criteria

• Living in institutions (e.g., nursing homes, prisons, military facilities, hospitals);
• Non-Portuguese speakers;
• Reduced physical and/or cognitive ability hampering participation (e.g., blindness, deafness, or cognitive impairment).