A Cohort Study on Early Stages of Heart Failure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorShanghai East Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥60 years

Cooperate in participating in research and sign informed consent forms

Disqualifiers

End stage heart failure patients

Refusal to participate in this study

Patients who are not suitable to participate in this study by Researchers's evaluation

Trial population

Elderly people who have signed informed consent forms for physical examinations in Beicai Community

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

8,000 Participants
are grouped into 1 trial group
Group A: Stages of Heart Failure in a Community-based Cohort China

Trial outcomes

Primary outcomes

1

All-cause mortality rate

All-cause mortality rate of different stages of heart failure

Time frame
10 years

Secondary outcomes

1

Prevalence of early heart failure

The prevalence of early heart failure was defined as morbidity of stage A heart failure and stage B heart failure. Stage A HF was defined as at risk for HF but without current or previous symptoms/signs of HF and without structural/functional heart disease or abnormal biomarkers.(eg. patients with hypertension, coronary artery disease, diabetes, obesity, atrial fibrillation/atrial flutter or tumour). Stage B HF was defined as no symptoms or signs of HF and evidence of one of the following:1) EF value\<52 in male and \<54 in female. 2) Increased NT-proBNP levels (≥125 pg/ml) or elevated TnT levels (\>0.017ng/ml).

Time frame
10 years
2

Progress of heart failure of Stage A

The morbidity rate of stage B heart failure, stage C heart failure and stage D heart failure in stage A heart failure patients in 2 year, 6 years and 10 years. Stage A HF was defined as at risk for HF but without current or previous symptoms/signs of HF and without structural/functional heart disease or abnormal biomarkers.(eg. patients with hypertension, coronary artery disease, diabetes, obesity, atrial fibrillation/atrial flutter or tumour). Stage B HF was defined as no symptoms or signs of HF and evidence of one of the following:1)EF value\<52 in male and \<54 in female.2) Increased NT-proBNP levels (≥125 pg/ml) or elevated TnT levels (\>0.017ng/ml). Stage C/D HF was defined as previous history of HF or structural heart disease with current or previous symptoms of HF (eg. dyspnea, swelling of both lower extremities), diagnosed by two cardiac specialists.

Time frame
Following up 10 years
3

Progress of heart failure of Stage B

The morbidity rate of stage C heart failure and stage D heart failure in stage B heart failure patients in 2 year, 6 years and 10 years. Stage B HF was defined as no symptoms or signs of HF and evidence of one of the following:1)EF value\<52 in male and \<54 in female.2) Increased NT-proBNP levels (≥125 pg/ml) or elevated TnT levels (\>0.017ng/ml). Stage C/D HF was defined as previous history of HF or structural heart disease with current or previous symptoms of HF (eg. dyspnea, swelling of both lower extremities), diagnosed by two cardiac specialists.

Time frame
Following up 10 years
4

Progress of heart failure of Stage C

The morbidity rate of stage D heart failure in stage C heart failure patients in 2 year, 6 years and 10 years. Stage C HF was defined as previous history of HF or structural heart disease with current or previous symptoms of HF (eg. dyspnea, swelling of both lower extremities). Stage D HF was defined as Marked HF symptoms that interfere with daily life and with recurrent hospitalizations despite attempts to optimize GDMT.

Time frame
Following up 10 years

Other outcomes

Sponsors and contacts

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Shanghai East Hospital

Lead sponsor

Beicai Community Health Service Center of Pudong District, Shanghai, China

Collaborator