Clinical trial NCT06673615: A Cohort Study on Early Stages of Heart Failure
Official title: A Community-based Cohort Study on Early Screening of Heart Failure in Elderly Population in Shanghai
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stages of Heart Failure
Keywords: Heart failure
Early screening
Elderly population
Epidemiology
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Beicai Community Health Service Center of Pudong District, Shanghai, China
First posted: 2024-11-05
Enrollment: 8000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly people who have signed informed consent forms for physical examinations in Beicai Community

Brief summary: The main goal of this observational study is to learn about the epidemiological characteristics of heart failure among elder population in Beicai community in Shanghai and construct a community-based database and biobank. The main question it aims to answer is:

What is the prevalence and prognosis of different stages of heart failure among elder population in community in Shanghai? And what are the influencing factors? What are the best screening strategies and hierarchical management strategies among different stages of heart failure patients in community? Participants are the elderly people aged 60 years or older in Beicai community in China. The follow-up will be programmed every 2 years.

Detailed description: Heart failure is a serious manifestation or advanced stage of various heart diseases with high mortality and re-hospitalization rates, and early diagnosis of heart failure is important to improve patient survival. Currently, the prevalence of preclinical heart failure (heart failure stage B) is lacking in China, and the rate of progression of heart failure from stage A/B to symptomatic heart failure (heart failure stage C) and end-stage heart failure (heart failure stage D) and the factors influencing the heart failure development are unknown.

The study is an ongoing prospective community-based study. After enrollment, a questionnaire, physical examination, laboratory examination and imaging examination will be administered to each participant at baseline and every 2 years in the follow-up. The laboratory and imaging examination include: blood/urine sample and biochemical measurements, electrocardiogram, echocardiograph, etc. In the follow-up, the incidence of cardiovascular disease, heart failure, other CV events and mortality will be recorded. Whether at baseline or follow-up, if the investigators find that patients are unclear about their disease status, the investigators will notify them by phone and record their subsequent medical behavior and results.

In this study, a community-based database and biobank will be established for early screening and long-term prognosis of heart failure in elderly population. Through the analysis of the data, the epidemiological characteristics of early stage of heart failure in elderly population in Shanghai can be identified and a multivariable model predicting heart failure in early stage will be constructed. Furtherly，the investigators will explore the referral criteria and hierarchical management strategies for heart failure through the cooperation between community hospitals and comprehensive hospitals.

Eligibility criteria: Inclusion Criteria:

1. Age ≥60 years
2. Cooperate in participating in research and sign informed consent forms

Exclusion Criteria:

1. End stage heart failure patients
2. Refusal to participate in this study
3. Patients who are not suitable to participate in this study by Researchers\&#39;s evaluation

Primary outcomes:
measure: All-cause mortality rate
timeFrame: 10 years
Secondary outcomes:
measure: Prevalence of early heart failure
timeFrame: 10 years
measure: Progress of heart failure of Stage A
timeFrame: Following up 10 years
measure: Progress of heart failure of Stage B
timeFrame: Following up 10 years
measure: Progress of heart failure of Stage C
timeFrame: Following up 10 years
measure: Clinical endpoints of heart failure
timeFrame: Following up 10 years
measure: New cardiovascular events
timeFrame: Following up 10 years
measure: Referral rate
timeFrame: 10 years
measure: Cardiovascular mortality rate
timeFrame: 10 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References: