Stages of Heart FailureNCT06673615
A Cohort Study on Early Stages of Heart Failure
An observational study of Stages of Heart Failure, run by Shanghai East Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stages of Heart Failure
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 30 Aug 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly people who have signed informed consent forms for physical examinations in Beicai Community
Who may be able to join
- Age ≥60 years
- Cooperate in participating in research and sign informed consent forms
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Xin Gon, Doctor, +86-021-38804518, 412900471@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stages of Heart Failure
- Keywords
- Heart failure, Early screening, Elderly population, Epidemiology
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rate
All-cause mortality rate of different stages of heart failure
Measured: 10 years
Secondary outcomes (8)
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).
Measured: 10 years
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.
Measured: Following up 10 years
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.
Measured: Following up 10 years
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.
Measured: Following up 10 years
Clinical endpoints of heart failure
Time of first occurrence of symptomatic heart failure. Symptomatic heart failure was defined as current or previous symptoms/signs of HF.
Measured: Following up 10 years
New cardiovascular events
Incidence rate of cardiovascular events
Measured: Following up 10 years
Referral rate
Proportion of patients referred to higher-level hospitals due to heart failure
Measured: 10 years
Cardiovascular mortality rate
Cardiovascular mortality rate of different stages of heart failure
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Apr 2024
- Primary completion30 Aug 2034 (estimated)
- Study completion30 Aug 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stages of Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beicai Community Health Service Center of Pudong District, Shanghai, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673615
- Sponsor's protocol ID
- XSDL-001
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gong X, Xu J, Wang M, Hu H, Yan Y, Han W, Huang J. Implementing community-based heart failure screening in primary care settings: a population-based pilot study in Shanghai, China. BMC Prim Care. 2025 Dec 18;27(1):19. doi: 10.1186/s12875-025-03124-1.
PubMed 41408608
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Cohort Study on Early Screening of Heart Failure in Elderly Population in Shanghai
- ClinicalTrials.gov ID
- NCT06673615
- Acronym / sponsor ID
- XSDL-001
- Conditions
- Stages of Heart Failure
- Keywords
- Heart failure, Early screening, Elderly population, Epidemiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Beicai Community Health Service Center of Pudong District, Shanghai, China
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Aug 2034 (estimated)
- Study completion
- 30 Aug 2044 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly people who have signed informed consent forms for physical examinations in Beicai Community
Key inclusion criteria (2 listed)
- Age ≥60 years
- Cooperate in participating in research and sign informed consent forms
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality rate
Time frame: 10 years
All-cause mortality rate of different stages of heart failure
8 secondary outcomes
Prevalence of early heart failure
Time frame: 10 years
Progress of heart failure of Stage A
Time frame: Following up 10 years
Progress of heart failure of Stage B
Time frame: Following up 10 years
Progress of heart failure of Stage C
Time frame: Following up 10 years
Clinical endpoints of heart failure
Time frame: Following up 10 years
New cardiovascular events
Time frame: Following up 10 years
Referral rate
Time frame: 10 years
Cardiovascular mortality rate
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 41408608Gong X, Xu J, Wang M, Hu H, Yan Y, Han W, Huang J. Implementing community-based heart failure screening in primary care settings: a population-based pilot study in Shanghai, China. BMC Prim Care. 2025 Dec 18;27(1):19. doi: 10.1186/s12875-025-03124-1.
- Individual participant dataSharing planned: Undecided
Related trials for Stages of Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingPhase 3
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stages of Heart Failure, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Han, Doctor (+86-021-38804518, dr.hanwei@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality rate (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06673615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.