Clinical trial NCT05434923: PORTHOS - PORTuguese Heart Failure Observational Study
Official title: PORTHOS - PORTuguese Heart Failure Observational Study: a Nationwide Epidemiological Study on Heart Failure and Asymptomatic Left Ventricle Systolic Dysfunction Based on Contemporary Diagnostic Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Prevalence
Heart failure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Sociedade Portuguesa de Cardiologia
name: NOVA Medical School
First posted: 2022-06-28
Enrollment: 6189
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community dwelling adults aged 50 years and above living in Mainland Portugal and registered in the National Health Service patients' database. Population will be stratified by age and gender.

Brief summary: 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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Prevalence of HF among the mainland resident Portuguese population aged 50 or above.
timeFrame: Between March 2022 and March 2023
Secondary outcomes:
measure: Age- and gender-specific prevalence of HF among the Portuguese population.
timeFrame: Between March 2022 and March 2023
measure: Heart Failure reduced Ejection Fraction phenotype prevalence.
timeFrame: Between March 2022 and March 2023
measure: Heart Failure mildly reduced Ejection Fraction phenotype prevalence
timeFrame: Between March 2022 and March 2023
measure: Heart Failure preserved Ejection Fraction phenotype prevalence.
timeFrame: Between March 2022 and March 2023
measure: Prevalence of asymptomatic NT-proBNP elevation.
timeFrame: Between March 2022 and March 2023
measure: Prevalence of Pre-HF, as defined by the HF universal definition 2, in patients with asymptomatic NT-proBNP elevation.
timeFrame: Between March 2022 and March 2023
measure: Prevalence of comorbidities among Portuguese HF patients
timeFrame: Between March 2022 and March 2023
measure: Prevalence of comorbidities among patients with HFrEF, HFmrEF, and HFpEF phenotypes.
timeFrame: Between March 2022 and March 2023
measure: Health-related quality of life 5-level Euro Quality of life-5D version (EQ-5D-5L)
timeFrame: Between March 2022 and March 2023
measure: Health-related quality of life (Kansas City Cardiomyopathy Questionnaire - KCCQ)
timeFrame: Between March 2022 and March 2023
measure: Association between health-related quality of life questionnaire (EQ-5D-5L) results and the HF phenotype.
timeFrame: Between March 2022 and March 2023
measure: Association between health-related quality of life questionnaire (KCCQ) results and the HF phenotype.
timeFrame: Between March 2022 and March 2023
Other outcomes:
measure: Exploratory Outcome: Association between pre-diabetes and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Association between diabetes mellitus and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Association between biomarkers of interest (HbA1c%) and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Association between biomarkers of interest (serum creatinine) and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Association between biomarkers of interest (C-reactive protein) and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Association between biomarkers of interest (troponin) and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Association between biomarkers of interest (lipids) and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Association between biomarkers of interest (HF biomarkers) and HF prevalence.
timeFrame: Between March 2022 and March 2023
measure: Exploratory Outcome: Distribution of HF according to geographical area using NUTS II segmentation.
timeFrame: Between March 2022 and March 2023
Locations:
city: Aljustrel
country: Portugal
facility: Research Site
city: Aveiro
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Castelo Branco
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lagos
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Serpa
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Silves
country: Portugal
facility: Research Site
city: Sobral de Monte Agraco
country: Portugal
facility: Research Site
city: Sobral de Monte Agraço
country: Portugal
facility: Research Site
city: Torres Vedras
country: Portugal
facility: Research Site
Study officials:
References: