PORTHOS - PORTuguese Heart Failure Observational Study

Heart Failure Clinical Trial

— PORTHOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05434923
• Other study ID #: D1699R00015
• Status: Completed
• Start date: June 30, 2022
• Est. completion date: September 18, 2023

Study information

• Verified date: October 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6189
• Est. completion date: September 18, 2023
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
AstraZeneca	NOVA Medical School, Sociedade Portuguesa de Cardiologia

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome: Association between pre-diabetes and HF prevalence.	Association between pre-diabetes and HF prevalence.	Between March 2022 and March 2023
Other	Exploratory Outcome: Association between diabetes mellitus and HF prevalence.	Association between diabetes mellitus and HF prevalence.	Between March 2022 and March 2023
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	Heart Failure reduced Ejection Fraction phenotype prevalence.	Heart Failure reduced Ejection Fraction phenotype prevalence.	Between March 2022 and March 2023
Secondary	Heart Failure mildly reduced Ejection Fraction phenotype prevalence	Heart Failure mildly reduced Ejection Fraction phenotype prevalence	Between March 2022 and March 2023
Secondary	Heart Failure preserved Ejection Fraction phenotype prevalence.	Heart Failure preserved Ejection Fraction phenotypes prevalence.	Between March 2022 and March 2023
Secondary	Prevalence of asymptomatic NT-proBNP elevation.	Prevalence of asymptomatic NT-proBNP elevation.	Between March 2022 and March 2023
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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