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Heart FailurePORTHOSNCT05434923

PORTHOS - PORTuguese Heart Failure Observational Study

An observational study of Heart Failure, run by AstraZeneca at 13 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Heart Failure
How many people
6,189 participants
Where
13 sitesPortugal
Study dates
30 Jun 2022to 18 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Portugal13 sites

  • Research Site

    Aljustrel

  • Research Site

    Aveiro

  • Research Site

    Braga

  • Research Site

    Castelo Branco

  • Research Site

    Coimbra

  • Research Site

    Lagos

  • Research Site

    Lisbon

  • Research Site

    Porto

  • Research Site

    Serpa

  • Research Site

    Setúbal

  • Research Site

    Silves

  • Research Site

    Sobral de Monte Agraço

  • Research Site

    Torres Vedras

Other trials in Portugal

About this 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

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

Read the 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.

Conditions
Heart Failure
Keywords
Prevalence, Heart failure
Medical subject headings
Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Between March 2022 and March 2023

Secondary outcomes (12)

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

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

    Measured: Between March 2022 and March 2023

  2. Heart Failure reduced Ejection Fraction phenotype prevalence.

    Heart Failure reduced Ejection Fraction phenotype prevalence.

    Measured: Between March 2022 and March 2023

  3. Heart Failure mildly reduced Ejection Fraction phenotype prevalence

    Heart Failure mildly reduced Ejection Fraction phenotype prevalence

    Measured: Between March 2022 and March 2023

  4. Heart Failure preserved Ejection Fraction phenotype prevalence.

    Heart Failure preserved Ejection Fraction phenotypes prevalence.

    Measured: Between March 2022 and March 2023

  5. Prevalence of asymptomatic NT-proBNP elevation.

    Prevalence of asymptomatic NT-proBNP elevation.

    Measured: Between March 2022 and March 2023

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

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

    Measured: Between March 2022 and March 2023

  7. Prevalence of comorbidities among Portuguese HF patients

    Prevalence of comorbidities among Portuguese HF patients, namely:

    1. CHD,
    2. previous MI,
    3. hypertension,
    4. obesity,
    5. DM,
    6. VHD,
    7. AF,
    8. CKD,
    9. COPD,
    10. OSA;

    Measured: Between March 2022 and March 2023

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

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

    1. CHD,
    2. previous MI,
    3. hypertension,
    4. obesity,
    5. DM,
    6. VHD,
    7. AF,
    8. CKD,
    9. COPD,
    10. OSA.

    Measured: Between March 2022 and March 2023

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

    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).

    Measured: Between March 2022 and March 2023

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

    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.

    Measured: Between March 2022 and March 2023

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

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

    Measured: Between March 2022 and March 2023

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

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

    Measured: Between March 2022 and March 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start30 Jun 2022
  3. Primary completion18 Sep 2023
  4. Study completion18 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
6,189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434923
Sponsor's protocol ID
D1699R00015
Acronym
PORTHOS
Status last verified
Aug 2024
First submitted
8 Jun 2022
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by AstraZeneca at 13 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of HF among the mainland resident Portuguese population aged 50 or above. (time frame: Between March 2022 and March 2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05434923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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