PORTHOS - PORTuguese Heart Failure Observational Study
PORTHOS
1 other identifier
observational
6,189
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2023
CompletedAugust 26, 2024
August 1, 2024
1.2 years
June 8, 2022
August 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Between March 2022 and March 2023
Secondary Outcomes (12)
Age- and gender-specific prevalence of HF among the Portuguese population.
Between March 2022 and March 2023
Heart Failure reduced Ejection Fraction phenotype prevalence.
Between March 2022 and March 2023
Heart Failure mildly reduced Ejection Fraction phenotype prevalence
Between March 2022 and March 2023
Heart Failure preserved Ejection Fraction phenotype prevalence.
Between March 2022 and March 2023
Prevalence of asymptomatic NT-proBNP elevation.
Between March 2022 and March 2023
- +7 more secondary outcomes
Other Outcomes (9)
Exploratory Outcome: Association between pre-diabetes and HF prevalence.
Between March 2022 and March 2023
Exploratory Outcome: Association between diabetes mellitus and HF prevalence.
Between March 2022 and March 2023
Exploratory Outcome: Association between biomarkers of interest (HbA1c%) and HF prevalence.
Between March 2022 and March 2023
- +6 more other outcomes
Eligibility Criteria
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.
You may qualify if:
- Community-dwelling citizens living in Mainland Portugal;
- Registration in a primary care centre;
- Age ≥50 years at recruitment;
- Voluntary signed informed consent.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Sociedade Portuguesa de Cardiologiacollaborator
- NOVA Medical Schoolcollaborator
Study Sites (13)
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
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
Related Links
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 28, 2022
Study Start
June 30, 2022
Primary Completion
September 18, 2023
Study Completion
September 18, 2023
Last Updated
August 26, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
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.