A Cohort Study on Early Stages of Heart Failure

November 2, 2024 updated by: Shanghai East Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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's evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Stages of Heart Failure in a Community-based Cohort China
A community-based cohort on stage A (at risk for HF), stage B (pre-HF) or stage C (symptomatic HF) of heart failure in China elderly people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality rate
Time Frame: 10 years
All-cause mortality rate of different stages of heart failure
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 years
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.
Following up 10 years
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.
Following up 10 years
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.
Following up 10 years
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.
Following up 10 years
New cardiovascular events
Time Frame: Following up 10 years
Incidence rate of cardiovascular events
Following up 10 years
Referral rate
Time Frame: 10 years
Proportion of patients referred to higher-level hospitals due to heart failure
10 years
Cardiovascular mortality rate
Time Frame: 10 years
Cardiovascular mortality rate of different stages of heart failure
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

August 30, 2034

Study Completion (Estimated)

August 30, 2044

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

November 2, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XSDL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe