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NCT Number: NCT03931200

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing hospital, Beijing, Beijing Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

China Cardiovascular Association

Other

Registry information

Official study title

Real World Demographic and Clinical Characteristics, Treatment Patterns and Clinical Outcomes of Heart Failure Patients in China: a Retrospective Non-Interventional Nationwide Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2019
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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