Heart FailureChina-HFNCT02664818
Study of China Heart Failure Registry to Investigate Characteristics of Patients in China
An observational study of Heart Failure, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess clinical characteristics, treatment, and outcome of patients hospitalized with heart failure in China and compared those with other registries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized with primary discharge diagnosis of heart failure
Who may be able to join
- Hospitalized patients with primary discharge diagnosis of heart failure according to current Chinese Heart Failure Guideline were recruited from January 2012.
Who cannot join
- Hospitals were excluded if they declined to participate or did not admit patients with heart failure.No other exclusion criteria were defined.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Dongfeng Gu, PH.D, 86 01088398630, gudongfeng@vip.sina.com
Jian Zhang, PH.D
About this study
Official title: China Heart Failure Registry Study: A Multicenter, Prospective Investigation of Clinical Characteristics, Treatment, and Outcome of Patients Hospitalized With Heart Failure
The purpose of this study is to assess clinical characteristics, treatment, and outcome of patients hospitalized with heart failure in China and compared those with other registries
Read the detailed description
- All sites were monitored randomly every year. Trained monitors were designated to monitor the process, compliance of enrollment criteria and accuracy of original data by visiting every site.
- In order to make sure the accuracy of data collected, we make some restrictions (range or format) and reminding functions in the electronic Case Report Form (eCRF).
- Detail information of each variable has been pre-defined. Staffs were trained before data entry.
- Standard Operating Procedures: Case data were collected by printed Case Report Form (CRF) and entered into a web-based data center (http://103.31.202.60/subFW/). Hospitals that did not complete eCRF would send printed CRF to data center. Trained clinicians or staffs were asked to enter these data into the web-based eCRF. Following variables were included in the database: (i) demography and characteristics of patients: age, gender, medical history, life style, precipitating factors of HF, laboratory tests, ECG, chest X-ray and comorbidities diagnosed at discharge. Physical examination, echocardiography, laboratory tests were performed at both admission and discharge; (ii) Heart failure management included pharmacological treatments (before admission, during hospitalization and at discharge), and nonpharmacological treatments (including coronary revascularization, implantable cardioverter-defibrillator, cardiac resynchronization therapy, pacemakers, and surgical or transcatheter valvular therapies, electrical conversion, intra aortic balloon pump, continuous renal replacement therapy, and invasive mechanical ventilation).The causes of in-hospital death included sudden death, cardiac death and non-cardiac death. All patients were followed up after discharge in outpatient department, or via electronic hospital records, or conversations with patients or patients' families by telephone. Outcomes for post-discharge included death (sudden death, cardiac death and non-cardiac death), and rehospitalization for heart failure deterioration, acute coronary syndrome, cardiac shock, syncope, and cardiac transplantation were recorded and entered into the web-based database. Information about physical examination, laboratory tests, ECG, chest X-ray, echocardiography, and costs and use of medications were collected at each follow-up visit.
- Sample size: A total of 15000 patients with heart failure were planned to be recruited from hospitals based on classification of economic-geographic regions in China, and a minimum number of patients were expected to enroll according to the number of hospitalized cases for each hospital. By September 2015, data from 13687 patients have been collected.
- Plan for missing data: Validated data was used to describe the clinical characteristics and treatment of patients without considering those missing. As for September 2015, the missing data on most of variables accounts for no more than 10% of all patients (n = 13687). Furthermore, variables obtained in multiple Logistic regression models (10318) for death were from over three quarters of (75.4%) of all patients. Simple and multiple imputation methods were not used in this study because of a large number of patients has been validated for analysis.
- Statistical analysis plan: Clinical characteristics, treatments, and outcomes were described by using means ± standard deviation or interquartile range (IQR) for continuous variables, and absolute numbers and percentages for categorical variables. The comparison of subgroups were performed by Student t-test or ANOVA for symmetrical continuous, Mann-Whitney U or Kruskal-Wallis H test for nonsymmetric continuous, and χ2 tests for categorical variables. Logistic regression was used to select potential risk factors for outcomes. Candidate variables associated with mortality in univariable Logistic regression analysis (P ≤ 0.20) were proceeded with multivariable analysis. Variables with significant P values (P < 0.05) were retained in the final multivariable model. Logarithmic transformation was performed to normalize the distribution of variables with skewed distribution. All P values of less than 0.05 from two-sided tests were accepted as statistically significant.
- Conditions
- Heart Failure
- Keywords
- Heart failure, China, Registry, Characteristic, Outcome
- 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 |
|---|---|---|
| Heart failure | Hospitalized patients with primary discharge diagnosis of heart failure and who were aged 18 years or older. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall composite of 9 performance measures for heart failure medications compliance.
- Prescribed rate of ACEIs/ARBs in patients with acute decompensated heart failure (ADHF) before admission.
- Prescribed rate of β blockers in patients with ADHF before admission.
- Prescribed rate of diuretics in patients with ADHF before admission.
- Prescribed rate of aldosterones in patients with ADHF before admission.
- Prescribed rate of ACEIs/ARBs in appropriate patients discharged alive.
- Prescribed rate of β blockers in appropriate patients discharged alive.
- Prescribed rate of diuretics in all patients discharged alive.
- Prescribed rate of aldosterones in appropriate patients discharged alive.
- Prescribed rate of warfarins in patients with nonvalvular atrial fibrillation and CHA2DS2-VASc score ≥2 discharged alive.
Measured: Duration of hospital stay, an expected average of 10 days
Secondary outcomes (1)
Number of deaths during index of hospitalization and after discharge.
Measured: Duration of hospital stay with an expected average of 10 days for in-hospital death; 1 year for patients discharged alive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2012
- Primary completionApr 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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
- 15,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jian Zhang, Ph. D, Study chair, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664818
- Sponsor's protocol ID
- 2011BA111B02
- Acronym
- China-HF
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data were abstracted by printed Case Report Form and entered into a web-based data center (http://103.31.202.60/subFW/). Hospitals that did not complete electronic CRF (eCRF) would send printed CRF to data center. Trained clinicians or staffs would enter these data into web-based eCRF.
Publications
Ai G, Zhou Q, Huang Y, Zhai M, Zhao X, Zhang Y, Zhang J. Combined impact of microalbuminuria and obesity on cardiovascular outcomes in hospitalized heart failure patients: a cohort study. BMC Cardiovasc Disord. 2026 Jun 29. doi: 10.1186/s12872-026-05944-0. Online ahead of print.
PubMed 42374188Wu Y, Zhang Y, Zhang J. Low Aortic Pulsatility Index and Pulmonary Artery Pulsatility Index Are Associated With Increased Mortality in Patients With Dilated Cardiomyopathy Awaiting Heart Transplantation. Korean Circ J. 2025 Feb;55(2):134-147. doi: 10.4070/kcj.2024.0192. Epub 2024 Oct 17.
PubMed 39506184Huang BP, Zhao L, Zhao XM, Zhai M, Huang Y, Zhou Q, Tian PC, Liang L, Huang LY, Feng JY, Zhang YH, Zhang J. Serum Potassium Levels and Mortality in Hospitalized Heart Failure Patients. Rev Cardiovasc Med. 2023 Aug 9;24(8):228. doi: 10.31083/j.rcm2408228. eCollection 2023 Aug.
PubMed 39076700Huang B, Huang Y, Zhai M, Zhou Q, Ji S, Liu H, Zhuang X, Zhang Y, Zhang J. Association of Sex With Cardiovascular Outcomes in Heart Failure Patients With Obstructive or Central Sleep Apnea. J Am Heart Assoc. 2024 Mar 5;13(5):e031186. doi: 10.1161/JAHA.123.031186. Epub 2024 Feb 27.
PubMed 38410942Wu Y, Tian P, Liang L, Chen Y, Feng J, Huang B, Huang L, Zhao X, Wang J, Guan J, Li X, Zhang Y, Zhang J. Afterload-related cardiac performance is a powerful hemodynamic predictor of mortality in patients with chronic heart failure. Ther Adv Chronic Dis. 2023 Jun 5;14:20406223231171554. doi: 10.1177/20406223231171554. eCollection 2023.
PubMed 37324410Zhao L, Zhao X, Tian P, Liang L, Huang B, Huang L, Feng J, Zhang Y, Zhang J. Predictive value of remnant cholesterol level for all-cause mortality in heart failure patients. Front Cardiovasc Med. 2023 Feb 15;10:1063562. doi: 10.3389/fcvm.2023.1063562. eCollection 2023.
PubMed 36873397Liang L, Zhao X, Huang L, Tian P, Huang B, Feng J, Zhou P, Wang J, Zhang J, Zhang Y. Prevalence and prognostic importance of malnutrition, as assessed by four different scoring systems, in elder patients with heart failure. Nutr Metab Cardiovasc Dis. 2023 May;33(5):978-986. doi: 10.1016/j.numecd.2023.01.004. Epub 2023 Jan 11.
PubMed 36710105Zhao L, Zhao X, Tian P, Liang L, Huang B, Huang L, Feng J, Zhang Y, Zhang J. Prognostic utility of the prognostic nutritional index combined with serum sodium level in patients with heart failure. Nutr Metab Cardiovasc Dis. 2022 Aug;32(8):1894-1902. doi: 10.1016/j.numecd.2022.04.004. Epub 2022 Apr 14.
PubMed 35637081
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Heart Failure Registry Study: A Multicenter, Prospective Investigation of Clinical Characteristics, Treatment, and Outcome of Patients Hospitalized With Heart Failure
- ClinicalTrials.gov ID
- NCT02664818
- Acronym / sponsor ID
- China-HF / 2011BA111B02
- Conditions
- Heart Failure
- Keywords
- Heart failure, China, Registry, Characteristic, Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- 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 purpose of this study is to assess clinical characteristics, treatment, and outcome of patients hospitalized with heart failure in China and compared those with other registries
Detailed description
- All sites were monitored randomly every year. Trained monitors were designated to monitor the process, compliance of enrollment criteria and accuracy of original data by visiting every site.
- In order to make sure the accuracy of data collected, we make some restrictions (range or format) and reminding functions in the electronic Case Report Form (eCRF).
- Detail information of each variable has been pre-defined. Staffs were trained before data entry.
- Standard Operating Procedures: Case data were collected by printed Case Report Form (CRF) and entered into a web-based data center (http://103.31.202.60/subFW/). Hospitals that did not complete eCRF would send printed CRF to data center. Trained clinicians or staffs were asked to enter these data into the web-based eCRF. Following variables were included in the database: (i) demography and characteristics of patients: age, gender, medical history, life style, precipitating factors of HF, laboratory tests, ECG, chest X-ray and comorbidities diagnosed at discharge. Physical examination, echocardiography, laboratory tests were performed at both admission and discharge; (ii) Heart failure management included pharmacological treatments (before admission, during hospitalization and at discharge), and nonpharmacological treatments (including coronary revascularization, implantable cardioverter-defibrillator, cardiac resynchronization therapy, pacemakers, and surgical or transcatheter valvular therapies, electrical conversion, intra aortic balloon pump, continuous renal replacement therapy, and invasive mechanical ventilation).The causes of in-hospital death included sudden death, cardiac death and non-cardiac death. All patients were followed up after discharge in outpatient department, or via electronic hospital records, or conversations with patients or patients' families by telephone. Outcomes for post-discharge included death (sudden death, cardiac death and non-cardiac death), and rehospitalization for heart failure deterioration, acute coronary syndrome, cardiac shock, syncope, and cardiac transplantation were recorded and entered into the web-based database. Information about physical examination, laboratory tests, ECG, chest X-ray, echocardiography, and costs and use of medications were collected at each follow-up visit.
- Sample size: A total of 15000 patients with heart failure were planned to be recruited from hospitals based on classification of economic-geographic regions in China, and a minimum number of patients were expected to enroll according to the number of hospitalized cases for each hospital. By September 2015, data from 13687 patients have been collected.
- Plan for missing data: Validated data was used to describe the clinical characteristics and treatment of patients without considering those missing. As for September 2015, the missing data on most of variables accounts for no more than 10% of all patients (n = 13687). Furthermore, variables obtained in multiple Logistic regression models (10318) for death were from over three quarters of (75.4%) of all patients. Simple and multiple imputation methods were not used in this study because of a large number of patients has been validated for analysis.
- Statistical analysis plan: Clinical characteristics, treatments, and outcomes were described by using means ± standard deviation or interquartile range (IQR) for continuous variables, and absolute numbers and percentages for categorical variables. The comparison of subgroups were performed by Student t-test or ANOVA for symmetrical continuous, Mann-Whitney U or Kruskal-Wallis H test for nonsymmetric continuous, and χ2 tests for categorical variables. Logistic regression was used to select potential risk factors for outcomes. Candidate variables associated with mortality in univariable Logistic regression analysis (P ≤ 0.20) were proceeded with multivariable analysis. Variables with significant P values (P < 0.05) were retained in the final multivariable model. Logarithmic transformation was performed to normalize the distribution of variables with skewed distribution. All P values of less than 0.05 from two-sided tests were accepted as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | –Hospitalized patients with primary discharge diagnosis of heart failure and who were aged 18 years or older. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized with primary discharge diagnosis of heart failure
Key inclusion criteria (1 listed)
- Hospitalized patients with primary discharge diagnosis of heart failure according to current Chinese Heart Failure Guideline were recruited from January 2012.
Key exclusion criteria (1 listed)
- Hospitals were excluded if they declined to participate or did not admit patients with heart failure.No other exclusion criteria were defined.
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
The overall composite of 9 performance measures for heart failure medications compliance.
Time frame: Duration of hospital stay, an expected average of 10 days
1. Prescribed rate of ACEIs/ARBs in patients with acute decompensated heart failure (ADHF) before admission. 2. Prescribed rate of β blockers in patients with ADHF before admission. 3. Prescribed rate of diuretics in patients with ADHF before admission. 4. Prescribed rate of aldosterones in patients with ADHF before admission. 5. Prescribed rate of ACEIs/ARBs in appropriate patients discharged alive. 6. Prescribed rate of β blockers in appropriate patients discharged alive. 7. Prescribed rate of diuretics in all patients discharged alive. 8. Prescribed rate of aldosterones in appropriate patients discharged alive. 9. Prescribed rate of warfarins in patients with nonvalvular atrial fibrillation and CHA2DS2-VASc score ≥2 discharged alive.
1 secondary outcome
Number of deaths during index of hospitalization and after discharge.
Time frame: Duration of hospital stay with an expected average of 10 days for in-hospital death; 1 year for patients discharged alive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 42374188Ai G, Zhou Q, Huang Y, Zhai M, Zhao X, Zhang Y, Zhang J. Combined impact of microalbuminuria and obesity on cardiovascular outcomes in hospitalized heart failure patients: a cohort study. BMC Cardiovasc Disord. 2026 Jun 29. doi: 10.1186/s12872-026-05944-0. Online ahead of print.
- Derived from this study: PubMed 39506184Wu Y, Zhang Y, Zhang J. Low Aortic Pulsatility Index and Pulmonary Artery Pulsatility Index Are Associated With Increased Mortality in Patients With Dilated Cardiomyopathy Awaiting Heart Transplantation. Korean Circ J. 2025 Feb;55(2):134-147. doi: 10.4070/kcj.2024.0192. Epub 2024 Oct 17.
- Derived from this study: PubMed 39076700Huang BP, Zhao L, Zhao XM, Zhai M, Huang Y, Zhou Q, Tian PC, Liang L, Huang LY, Feng JY, Zhang YH, Zhang J. Serum Potassium Levels and Mortality in Hospitalized Heart Failure Patients. Rev Cardiovasc Med. 2023 Aug 9;24(8):228. doi: 10.31083/j.rcm2408228. eCollection 2023 Aug.
- Derived from this study: PubMed 38410942Huang B, Huang Y, Zhai M, Zhou Q, Ji S, Liu H, Zhuang X, Zhang Y, Zhang J. Association of Sex With Cardiovascular Outcomes in Heart Failure Patients With Obstructive or Central Sleep Apnea. J Am Heart Assoc. 2024 Mar 5;13(5):e031186. doi: 10.1161/JAHA.123.031186. Epub 2024 Feb 27.
- Derived from this study: PubMed 37324410Wu Y, Tian P, Liang L, Chen Y, Feng J, Huang B, Huang L, Zhao X, Wang J, Guan J, Li X, Zhang Y, Zhang J. Afterload-related cardiac performance is a powerful hemodynamic predictor of mortality in patients with chronic heart failure. Ther Adv Chronic Dis. 2023 Jun 5;14:20406223231171554. doi: 10.1177/20406223231171554. eCollection 2023.
- Derived from this study: PubMed 36873397Zhao L, Zhao X, Tian P, Liang L, Huang B, Huang L, Feng J, Zhang Y, Zhang J. Predictive value of remnant cholesterol level for all-cause mortality in heart failure patients. Front Cardiovasc Med. 2023 Feb 15;10:1063562. doi: 10.3389/fcvm.2023.1063562. eCollection 2023.
- Derived from this study: PubMed 36710105Liang L, Zhao X, Huang L, Tian P, Huang B, Feng J, Zhou P, Wang J, Zhang J, Zhang Y. Prevalence and prognostic importance of malnutrition, as assessed by four different scoring systems, in elder patients with heart failure. Nutr Metab Cardiovasc Dis. 2023 May;33(5):978-986. doi: 10.1016/j.numecd.2023.01.004. Epub 2023 Jan 11.
- Derived from this study: PubMed 35637081Zhao L, Zhao X, Tian P, Liang L, Huang B, Huang L, Feng J, Zhang Y, Zhang J. Prognostic utility of the prognostic nutritional index combined with serum sodium level in patients with heart failure. Nutr Metab Cardiovasc Dis. 2022 Aug;32(8):1894-1902. doi: 10.1016/j.numecd.2022.04.004. Epub 2022 Apr 14.
- Data were abstracted by electronic form created in this web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data were abstracted by printed Case Report Form and entered into a web-based data center (http://103.31.202.60/subFW/). Hospitals that did not complete electronic CRF (eCRF) would send printed CRF to data center. Trained clinicians or staffs would enter these data into web-based eCRF.
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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. This study is not recruiting at the moment.
Jian Zhang, Ph. D study chair
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Heart Failure, run by Chinese Academy of Medical Sciences, Fuwai 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongcheng Zhang, Ph. D (86 (10) 8839 8170 ext. 86 18610875308, zrc1982916@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall composite of 9 performance measures for heart failure medications compliance. (time frame: Duration of hospital stay, an expected average of 10 days). 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 NCT02664818, which also lists 8 linked publications.
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 27 Jan 2016.