Demographic and Clinical Characteristics, Treatment Patterns and Clinical Outcomes of Heart Failure Patients in China

• ClinicalTrials.gov Identifier: NCT03931200
• Recruitment Status: Completed
• First Posted: April 30, 2019
• Last Update Posted: May 21, 2019
• Sponsor: China Cardiovascular Association
• Information provided by (Responsible Party): China Cardiovascular Association

Study Description

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.

Condition or disease
Heart Failure

Detailed Description:

Research question and objectives Primary objective

• Describe the demographic and clinical characteristics of HF patients at HF index hospitalization admission Secondary objective
• Assess the HF diagnosis and evaluation patterns and treatment patterns during index hospitalization and after discharge compare with guideline (2018 China HF Guideline) recommendations
• Describe the demographic characteristics, clinical characteristics, diagnostic pattern, treatment pattern of HF patients stratified by LVEF (left ventricular ejection fraction) and region Exploratory objectives Describe the demographic and clinical characteristics, sac/val start dose and titration pattern among chronic HF patients prescribed sac/val

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

• Aged 18 years and older
• Patients with confirmed diagnosis of HF
• Diagnosis is made by the treating physicians according to local practices and their clinical judgement Exclusion criteria Concomitant participation in a clinical study with any investigational treatment during the index hospitalization

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).

Study Design

• 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

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Patients' demographics at index hospitalization admission. [ Time Frame: 1 years ]
   Patients' demographics at index hospitalization admission.
2. Patients' medical history at index hospitalization admission. [ Time Frame: 1 years ]
   Patients' medical history at index hospitalization admission.
3. Patients' comorbidities (i.e. diabetes, renal insufficiency, chronic obstructive pulmonary disease, anemia, obesity, hypertension) at index hospitalization admission. [ Time Frame: 1 years ]
   Patients' comorbidities (i.e. diabetes, renal insufficiency, chronic obstructive pulmonary disease, anemia, obesity, hypertension) at index hospitalization admission.

Secondary Outcome Measures :

1. The percentage of patients who received the guideline (2018 China HF Guideline) recommended tests during the indexed hospitalization. [ Time Frame: 1 years ]
   The percentage of patients who received the guideline (2018 China HF Guideline) recommended tests (i.e. echocardiography, electrocardiogram, brain natriuretic peptide (BNP)/n-terminal pro-brain natriuretic Peptide (NT-proBNP)) during the indexed hospitalization.
2. The percentage of HF patients who received the guideline (2018 China HF Guideline) recommended HFrEF (Hear failure with reduced ejection fraction) pharmacological and device treatments (i.e. ICD, CRT) at the discharge of the index hospitalization. [ Time Frame: 1 years ]
   The percentage of HF patients who received the guideline (2018 China HF Guideline) recommended HFrEF pharmacological (i.e. Angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), ARNI, β-blockers, aldosterone antagonists, diuretics) and device treatments (i.e. ICD, CRT) at the discharge of the index hospitalization.
3. The percentage of HF patients adherent to guideline. [ Time Frame: 1 years ]
   The percentage of HF patients adherent to guideline (2018 China HF Guideline) recommended HFrEF pharmacological treatments including ACEIs, ARBs, β-blockers, aldosterone antagonists and diuretics at 1 month, 3 months and 1 year after discharge from the indexed hospitalization.
4. Follow-up rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. [ Time Frame: 1 years ]
   Follow-up rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.
5. In-hospital mortality rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. [ Time Frame: 1 years ]
   In-hospital mortality rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.
6. Re-hospitalization rate at 1month, 3 months and 1 year after discharge from indexed hospitalization. [ Time Frame: 1 years ]
   Re-hospitalization rate at 1month, 3 months and 1 year after discharge from indexed hospitalization.
7. Demographic characteristics among HF patients stratified by LVEF (<40%/40-49%/≥50%). [ Time Frame: 1 years ]
   Demographic characteristics among HF patients stratified by LVEF (<40%/40-49%/≥50%).
8. Medical history among HF patients stratified by LVEF (<40%/40-49%/≥50%). [ Time Frame: 1 years ]
   Medical history among HF patients stratified by LVEF (<40%/40-49%/≥50%).
9. Diagnostic pattern among HF patients stratified by LVEF (<40%/40-49%/≥50%). [ Time Frame: 1 years ]
   Diagnostic pattern among HF patients stratified by LVEF (<40%/40-49%/≥50%).
10. Treatment pattern among HF patients stratified by LVEF (<40%/40-49%/≥50%). [ Time Frame: 1 years ]
    Treatment pattern among HF patients stratified by LVEF (<40%/40-49%/≥50%).
11. Outcomes among HF patients stratified by LVEF (<40%/40-49%/≥50%). [ Time Frame: 1 years ]
    Outcomes among HF patients stratified by LVEF (<40%/40-49%/≥50%).
12. Demographic characteristics comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. [ Time Frame: 1 years ]
    Demographic characteristics comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.
13. Medical history comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. [ Time Frame: 1 years ]
    Medical history comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.
14. Diagnostic pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. [ Time Frame: 1 years ]
    Diagnostic pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.
15. Treatment pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. [ Time Frame: 1 years ]
    Treatment pattern comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.
16. Outcomes comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China. [ Time Frame: 1 years ]
    Outcomes comparing HF patients in Shanghai vs the whole of China and Shanghai vs the rest of China.

Eligibility Criteria

• 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

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.

Criteria

Inclusion Criteria:

• Aged 18 years and older
• Patients with confirmed diagnosis of HF
• Diagnosis is made by the treating physicians according to local practices and their clinical judgement

Exclusion Criteria:

• Concomitant participation in any/a clinical trial with any investigational treatment during the index hospitalization

Contacts and Locations

Locations

China, Beijing

Peking University First Hospital

Beijing, Beijing, China, 100034

Beijing hospital

Beijing, Beijing, China, 100730

Sponsors and Collaborators

China Cardiovascular Association

More Information

Publications:

Gu DF, Huang GY, He J, et al (2003). Investigation of prevalence and distributing feature of chronic heart failure in Chinese adult population. Chin J Cardiol, Vol.31,pp.3-6.

Huang J, Yin H, Zhang M, Ni Q, Xuan J. Understanding the economic burden of heart failure in China: impact on disease management and resource utilization. J Med Econ. 2017 May;20(5):549-553. doi: 10.1080/13696998.2017.1297309. Epub 2017 Mar 12.

Zhang Y, Zhang J, Butler J, Yang X, Xie P, Guo D, Wei T, Yu J, Wu Z, Gao Y, Han X, Zhang X, Wen S, Anker SD, Filippatos G, Fonarow GC, Gan T, Zhang R; China-HF Investigators. Contemporary Epidemiology, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: Results From the China Heart Failure (China-HF) Registry. J Card Fail. 2017 Dec;23(12):868-875. doi: 10.1016/j.cardfail.2017.09.014. Epub 2017 Oct 10.

ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8.

• Responsible Party: China Cardiovascular Association
• ClinicalTrials.gov Identifier: NCT03931200
• Other Study ID Numbers: GUSU19002
• First Posted: April 30, 2019
• Last Update Posted: May 21, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases