PORTHOS - PORTuguese Heart Failure Observational Study (PORTHOS)

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 6189

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com
• Study Contact Backup: Name: Sociedade Portuguesa de Cardiologia; Email: porthos@spc.pt

Study Locations

• Portugal
  • 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
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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: CHD,; previous MI,; hypertension,; obesity,; DM,; VHD,; AF,; CKD,; COPD,; OSA;	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: CHD,; previous MI,; hypertension,; obesity,; DM,; VHD,; AF,; CKD,; COPD,; OSA.	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: NOVA Medical School; Sociedade Portuguesa de Cardiologia

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): September 18, 2023
• Study Completion (Actual): September 18, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Prevalence; Heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: D1699R00015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No