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| Name | Class |
|---|---|
| Sociedade Portuguesa de Cardiologia | UNKNOWN |
| NOVA Medical School | OTHER |
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between March 2022 and March 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Age- and gender-specific prevalence of HF among the Portuguese population. | Age- and gender-specific prevalence of HF among the Portuguese population. | Between March 2022 and March 2023 |
| Heart Failure reduced Ejection Fraction phenotype prevalence. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome: Association between pre-diabetes and HF prevalence. | Association between pre-diabetes and HF prevalence. | Between March 2022 and March 2023 |
| Exploratory Outcome: Association between diabetes mellitus and HF prevalence. |
Inclusion Criteria:
Exclusion criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aljustrel | Portugal | ||||
| Research Site |
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| Label | URL |
|---|---|
| redacted CSR Synopsis | View source |
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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.
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.
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.
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Blood samples
Heart Failure reduced Ejection Fraction phenotype prevalence.
| Between March 2022 and March 2023 |
| Heart Failure mildly reduced Ejection Fraction phenotype prevalence | Heart Failure mildly reduced Ejection Fraction phenotype prevalence | Between March 2022 and March 2023 |
| Heart Failure preserved Ejection Fraction phenotype prevalence. | Heart Failure preserved Ejection Fraction phenotypes prevalence. | Between March 2022 and March 2023 |
| Prevalence of asymptomatic NT-proBNP elevation. | Prevalence of asymptomatic NT-proBNP elevation. | 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. | Prevalence of Pre-HF, as defined by the HF universal definition 2, in patients with asymptomatic NT-proBNP elevation. | Between March 2022 and March 2023 |
| Prevalence of comorbidities among Portuguese HF patients | Prevalence of comorbidities among Portuguese HF patients, namely:
| Between March 2022 and March 2023 |
| Prevalence of comorbidities among patients with HFrEF, HFmrEF, and HFpEF phenotypes. | Prevalence of comorbidities among patients with HFrEF, HFmrEF, and HFpEF phenotypes, namely:
| Between March 2022 and March 2023 |
| 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). | Between March 2022 and March 2023 |
| 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. | Between March 2022 and March 2023 |
| 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. | Between March 2022 and March 2023 |
| 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. | Between March 2022 and March 2023 |
Association between diabetes mellitus and HF prevalence.
| Between March 2022 and March 2023 |
| Exploratory Outcome: Association between biomarkers of interest (HbA1c%) and HF prevalence. | Association between biomarkers of interest (HbA1c%) and HF prevalence. | Between March 2022 and March 2023 |
| Exploratory Outcome: Association between biomarkers of interest (serum creatinine) and HF prevalence. | Association between biomarkers of interest (serum creatinine) and HF prevalence. | Between March 2022 and March 2023 |
| Exploratory Outcome: Association between biomarkers of interest (C-reactive protein) and HF prevalence. | Association between biomarkers of interest (C-reactive protein) and HF prevalence. | Between March 2022 and March 2023 |
| Exploratory Outcome: Association between biomarkers of interest (troponin) and HF prevalence. | Association between biomarkers of interest (troponin) and HF prevalence. | Between March 2022 and March 2023 |
| Exploratory Outcome: Association between biomarkers of interest (lipids) and HF prevalence. | Association between biomarkers of interest (lipids) and HF prevalence. | Between March 2022 and March 2023 |
| Exploratory Outcome: Association between biomarkers of interest (HF biomarkers) and HF prevalence. | Association between biomarkers of interest (HF biomarkers) and HF prevalence. | Between March 2022 and March 2023 |
| Exploratory Outcome: Distribution of HF according to geographical area using NUTS II segmentation. | Distribution of HF according to geographical area using NUTS II segmentation. | Between March 2022 and March 2023 |
| Aveiro |
| Portugal |
| Research Site | Braga | Portugal |
| Research Site | Castelo Branco | Portugal |
| Research Site | Coimbra | Portugal |
| Research Site | Lagos | Portugal |
| Research Site | Lisbon | Portugal |
| Research Site | Porto | Portugal |
| Research Site | Serpa | Portugal |
| Research Site | Setúbal | Portugal |
| Research Site | Silves | Portugal |
| Research Site | Sobral de Monte Agraço | Portugal |
| Research Site | Torres Vedras | Portugal |