PORTHOS - PORTuguese Heart Failure Observational Study

NCT ID: NCT05434923

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-09-18

Brief Summary

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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

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sociedade Portuguesa de Cardiologia

UNKNOWN

Sponsor Role collaborator

NOVA Medical School

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Aljustrel, , Portugal

Site Status

Research Site

Aveiro, , Portugal

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Research Site

Braga, , Portugal

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Research Site

Castelo Branco, , Portugal

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Research Site

Coimbra, , Portugal

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Research Site

Lagos, , Portugal

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Research Site

Lisbon, , Portugal

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Research Site

Porto, , Portugal

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Research Site

Serpa, , Portugal

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Research Site

Setúbal, , Portugal

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Research Site

Silves, , Portugal

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Research Site

Sobral de Monte Agraço, , Portugal

Site Status

Research Site

Torres Vedras, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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D1699R00015

Identifier Type: -

Identifier Source: org_study_id

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