Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06673615

A Cohort Study on Early Stages of Heart Failure

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stages of Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location status: Recruiting

Location contact

Xin Gon, Doctor

CONTACT

[email protected]

+86-021-38804518

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥60 years
  • Cooperate in participating in research and sign informed consent forms

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. All-cause mortality rate

    Time frame: 10 years

    All-cause mortality rate of different stages of heart failure

Secondary outcomes

  1. Prevalence of early heart failure

    Time frame: 10 years

    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).

  2. Progress of heart failure of Stage A

    Time frame: Following up 10 years

    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.

  3. Progress of heart failure of Stage B

    Time frame: Following up 10 years

    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.

  4. Progress of heart failure of Stage C

    Time frame: Following up 10 years

    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.

  5. Clinical endpoints of heart failure

    Time frame: Following up 10 years

    Time of first occurrence of symptomatic heart failure. Symptomatic heart failure was defined as current or previous symptoms/signs of HF.

  6. New cardiovascular events

    Time frame: Following up 10 years

    Incidence rate of cardiovascular events

  7. Referral rate

    Time frame: 10 years

    Proportion of patients referred to higher-level hospitals due to heart failure

  8. Cardiovascular mortality rate

    Time frame: 10 years

    Cardiovascular mortality rate of different stages of heart failure

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Han, Doctor

CONTACT

[email protected]

+86-021-38804518

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Collaborators

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

Registry information

Official study title

A Community-based Cohort Study on Early Screening of Heart Failure in Elderly Population in Shanghai

Important dates

Study start
2024
Primary completion
2034
Study completion
2044
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.