Condition or disease |
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Heart Failure |
Study Type : | Observational |
Actual Enrollment : | 60000 participants |
Observational Model: | Other |
Time Perspective: | Retrospective |
Official Title: | Real World Demographic and Clinical Characteristics, Treatment Patterns and Clinical Outcomes of Heart Failure Patients in China: a Retrospective Non-Interventional Nationwide Study |
Actual Study Start Date : | April 30, 2019 |
Actual Primary Completion Date : | May 18, 2019 |
Actual Study Completion Date : | May 18, 2019 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
• Concomitant participation in any/a clinical trial with any investigational treatment during the index hospitalization
China, Beijing | |
Peking University First Hospital | |
Beijing, Beijing, China, 100034 | |
Beijing hospital | |
Beijing, Beijing, China, 100730 |
Tracking Information | |||||
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First Submitted Date | April 15, 2019 | ||||
First Posted Date | April 30, 2019 | ||||
Last Update Posted Date | May 21, 2019 | ||||
Actual Study Start Date | April 30, 2019 | ||||
Actual Primary Completion Date | May 18, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Demographic and Clinical Characteristics, Treatment Patterns and Clinical Outcomes of Heart Failure Patients in China | ||||
Official Title | Real World Demographic and Clinical Characteristics, Treatment Patterns and Clinical Outcomes of Heart Failure Patients in China: a Retrospective Non-Interventional Nationwide Study | ||||
Brief Summary | This is a non-interventional, multicenter, retrospective study assessing demographic characteristics, clinical characteristics, management and outcome of patients with a HF (heart failure) diagnosis utilizing real world data derived from HF Center Database. This database collects the data of HF from patients hospitalized between March 2010 to Dec 2018 in more than 300 hospitals across China. | ||||
Detailed Description |
Research question and objectives Primary objective
Study design This is a non-interventional, multicenter, retrospective study assessing demographic characteristics, clinical characteristics, management and outcome of patients with a HF diagnosis utilizing real world data derived from HF Center Database. This database collects the data of HF from patients hospitalized between March 2010 to Dec 2018 in more than 300 hospitals across China. Setting and study population This study will include the data from all patients who were enrolled in the HF Center database. The study population consists of adult inhospital patients (18+ years) being diagnosed with HF at discharge. Inclusion criteria
Variables Collection at index hospitalization: Demography Comorbidities and Medical History Patient presentation at admission (including signs and symptoms) Vital Status In-hospital evaluation tests (laboratories, function tests, etc) Medication at discharge Collection at follow-up (1 month, 3months and 1year): Vital status Evaluation tests (laboratories, function tests, etc) Medication at follow-up Clinical outcomes (mortality and re-hospitalization events where feasible) Data sources The data from this study will be retrieved from the HF Center database provided by CHH (China Heart House). All data were collected from more than 300 collaborative hospitals of China, including approximately 60,000 patients of HF. The information was collected during index hospitalization, 1 month, 3 months, 1 year after discharge by trained coordinators using a standardized case report form, entered into the HF Center database. Study size This study will be conducted based on existing database and no formal sample size calculation is necessary for this type of descriptive retrospective observational research. In HF Center database, there is around 60,000 patients in total planned to be analyzed in this study. Data analysis Descriptive data analyses will be focus on: (1) Continuous variables: mean, standard error, median, first quartile, third quartile, ranges for continuous variables; (2) Categorical variables: frequencies, and percentages for categorical variables. Summaries will be presented together with estimates and corresponding 95% confidence intervals (CI) as appropriate. For the endpoints that stratified by LVEF and region, differences will be assessed by the p-values of corresponding tests. Categorical variables will be compared using chi-square tests; continuous variables will be compared using unequal variance two-sample t-test; for continuous variables with skewed data Mann-Whitney U test will be used, or Wilcoxon signed-rank test in case of paired data. 95% confidence intervals (CIs) and two tailed p-value will be reported for the parameter estimated in the multivariable models. The number and proportion of patients with missing data will be presented. Detailed description will be provided in the SAP (Statistical Analysis Plan). |
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Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | The demographic and clinical characteristics were collected from patients' medical records during their in-patients treatment period, and the follow-up data were collected from face-to-face interview at outpatient clinics or phone interview after discharge. | ||||
Condition | Heart Failure | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
60000 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | May 18, 2019 | ||||
Actual Primary Completion Date | May 18, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: • Concomitant participation in any/a clinical trial with any investigational treatment during the index hospitalization |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03931200 | ||||
Other Study ID Numbers | GUSU19002 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | China Cardiovascular Association | ||||
Study Sponsor | China Cardiovascular Association | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | China Cardiovascular Association | ||||
Verification Date | April 2019 |