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

Heart Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT03931200
• Study type: Observational
• Source: China Cardiovascular Association
• Status: Completed
• Start date: April 30, 2019
• Completion date: May 18, 2019