PORTHOS - PORTuguese Heart Failure Observational Study: a Nationwide Epidemiological Study on Heart Failure and Asymptomatic Left Ventricle Systolic Dysfunction Based on Contemporary Diagnostic Tools
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 6,189
- 试验地点
- 1
- 主要终点
- Prevalence of HF among the mainland resident Portuguese population aged 50 or above.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
结局指标
主要结局
Prevalence of HF among the mainland resident Portuguese population aged 50 or above.
时间窗: Between March 2022 and March 2023
Prevalence of HF among the mainland resident Portuguese population aged 50 or above.
次要结局
- Heart Failure reduced Ejection Fraction phenotype prevalence.(Between March 2022 and March 2023)
- Heart Failure preserved Ejection Fraction phenotype prevalence.(Between March 2022 and March 2023)
- Age- and gender-specific prevalence of HF among the Portuguese population.(Between March 2022 and March 2023)
- Prevalence of asymptomatic NT-proBNP elevation.(Between March 2022 and March 2023)
- Heart Failure mildly reduced Ejection Fraction phenotype prevalence(Between March 2022 and March 2023)
- Prevalence of comorbidities among Portuguese HF patients(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.(Between March 2022 and March 2023)
- Association between health-related quality of life questionnaire (EQ-5D-5L) results and the HF phenotype.(Between March 2022 and March 2023)
- Prevalence of comorbidities among patients with HFrEF, HFmrEF, and HFpEF phenotypes.(Between March 2022 and March 2023)
- Health-related quality of life 5-level Euro Quality of life-5D version (EQ-5D-5L)(Between March 2022 and March 2023)
- Health-related quality of life (Kansas City Cardiomyopathy Questionnaire - KCCQ)(Between March 2022 and March 2023)
- Association between health-related quality of life questionnaire (KCCQ) results and the HF phenotype.(Between March 2022 and March 2023)