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PORTHOS - PORTuguese Heart Failure Observational Study (PORTHOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05434923
Recruitment Status : Completed
First Posted : June 28, 2022
Last Update Posted : October 13, 2023
Sponsor:
Collaborators:
Sociedade Portuguesa de Cardiologia
NOVA Medical School
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

Condition or disease
Heart Failure

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.
Study Design
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Study Type : Observational
Actual Enrollment : 6189 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Actual Study Start Date : June 30, 2022
Actual Primary Completion Date : September 18, 2023
Actual Study Completion Date : September 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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:

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

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


Biospecimen Retention:   Samples Without DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05434923


Locations
Layout table for location information
Portugal
Research Site
Aljustrel, Portugal
Research Site
Aveiro, Portugal
Research Site
Braga, Portugal
Research Site
Castelo Branco, Portugal
Research Site
Coimbra, Portugal
Research Site
Lagos, Portugal
Research Site
Lisboa, Portugal
Research Site
Porto, Portugal
Research Site
Serpa, Portugal
Research Site
Setubal, Portugal
Research Site
Silves, Portugal
Research Site
Sobral de Monte Agraco, Portugal
Research Site
Sobral de Monte Agraço, Portugal
Research Site
Torres Vedras, Portugal
Sponsors and Collaborators
AstraZeneca
Sociedade Portuguesa de Cardiologia
NOVA Medical School
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05434923    
Other Study ID Numbers: D1699R00015
First Posted: June 28, 2022    Key Record Dates
Last Update Posted: October 13, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Prevalence
Heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases