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Completed

NCT Number: NCT05434923

PORTHOS - PORTuguese Heart Failure Observational Study

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aljustrel, Portugal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Prevalence of HF among the mainland resident Portuguese population aged 50 or above.

    Time frame: Between March 2022 and March 2023

    Prevalence of HF among the mainland resident Portuguese population aged 50 or above.

Secondary outcomes

  1. Age- and gender-specific prevalence of HF among the Portuguese population.

    Time frame: Between March 2022 and March 2023

    Age- and gender-specific prevalence of HF among the Portuguese population.

  2. Heart Failure reduced Ejection Fraction phenotype prevalence.

    Time frame: Between March 2022 and March 2023

    Heart Failure reduced Ejection Fraction phenotype prevalence.

  3. Heart Failure mildly reduced Ejection Fraction phenotype prevalence

    Time frame: Between March 2022 and March 2023

    Heart Failure mildly reduced Ejection Fraction phenotype prevalence

  4. Heart Failure preserved Ejection Fraction phenotype prevalence.

    Time frame: Between March 2022 and March 2023

    Heart Failure preserved Ejection Fraction phenotypes prevalence.

  5. Prevalence of asymptomatic NT-proBNP elevation.

    Time frame: Between March 2022 and March 2023

    Prevalence of asymptomatic NT-proBNP elevation.

  6. Prevalence of Pre-HF, as defined by the HF universal definition 2, in patients with asymptomatic NT-proBNP elevation.

    Time frame: Between March 2022 and March 2023

    Prevalence of Pre-HF, as defined by the HF universal definition 2, in patients with asymptomatic NT-proBNP elevation.

  7. Prevalence of comorbidities among Portuguese HF patients

    Time frame: Between March 2022 and March 2023

    Prevalence of comorbidities among Portuguese HF patients, namely:

    • CHD,
    • previous MI,
    • hypertension,
    • obesity,
    • DM,
    • VHD,
    • AF,
    • CKD,
    • COPD,
    • OSA;

  8. Prevalence of comorbidities among patients with HFrEF, HFmrEF, and HFpEF phenotypes.

    Time frame: Between March 2022 and March 2023

    Prevalence of comorbidities among patients with HFrEF, HFmrEF, and HFpEF phenotypes, namely:

    • CHD,
    • previous MI,
    • hypertension,
    • obesity,
    • DM,
    • VHD,
    • AF,
    • CKD,
    • COPD,
    • OSA.

  9. Health-related quality of life 5-level Euro Quality of life-5D version (EQ-5D-5L)

    Time frame: Between March 2022 and March 2023

    Health-related quality of life 5-level Euro Quality of life-5D version (EQ-5D-5L) consists of 2 pages: the descriptive system (EQ-5D) and the visual analogue scale (EQ VAS).

    EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; each one has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0).

  10. Health-related quality of life (Kansas City Cardiomyopathy Questionnaire - KCCQ)

    Time frame: Between March 2022 and March 2023

    Health-related quality of life (Kansas City Cardiomyopathy Questionnaire - KCCQ).

    The predictor was the annually updated KCCQ score. The KCCQ is a validated instrument to assess health status among persons with heart failure. The self-administered questionnaire includes 23-items which quantify the importance of dyspnea, fatigue, and edema on physical, social, and emotional functions. The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three subscale scores.

  11. Association between health-related quality of life questionnaire (EQ-5D-5L) results and the HF phenotype.

    Time frame: Between March 2022 and March 2023

    Association between health-related quality of life questionnaire (EQ-5D-5L) results and the HF phenotype.

  12. Association between health-related quality of life questionnaire (KCCQ) results and the HF phenotype.

    Time frame: Between March 2022 and March 2023

    Association between health-related quality of life questionnaire (KCCQ) results and the HF phenotype.

Other outcomes

  1. Exploratory Outcome: Association between pre-diabetes and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between pre-diabetes and HF prevalence.

  2. Exploratory Outcome: Association between diabetes mellitus and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between diabetes mellitus and HF prevalence.

  3. Exploratory Outcome: Association between biomarkers of interest (HbA1c%) and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between biomarkers of interest (HbA1c%) and HF prevalence.

  4. Exploratory Outcome: Association between biomarkers of interest (serum creatinine) and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between biomarkers of interest (serum creatinine) and HF prevalence.

  5. Exploratory Outcome: Association between biomarkers of interest (C-reactive protein) and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between biomarkers of interest (C-reactive protein) and HF prevalence.

  6. Exploratory Outcome: Association between biomarkers of interest (troponin) and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between biomarkers of interest (troponin) and HF prevalence.

  7. Exploratory Outcome: Association between biomarkers of interest (lipids) and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between biomarkers of interest (lipids) and HF prevalence.

  8. Exploratory Outcome: Association between biomarkers of interest (HF biomarkers) and HF prevalence.

    Time frame: Between March 2022 and March 2023

    Association between biomarkers of interest (HF biomarkers) and HF prevalence.

  9. Exploratory Outcome: Distribution of HF according to geographical area using NUTS II segmentation.

    Time frame: Between March 2022 and March 2023

    Distribution of HF according to geographical area using NUTS II segmentation.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • NOVA Medical School
  • Sociedade Portuguesa de Cardiologia

Registry information

Official study 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

Acronym: PORTHOS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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