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Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China

Sponsor
Peking University First Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06099028
Collaborator
China Cardiovascular Association (Other), AstraZeneca (Industry)
22,500
Enrollment
1
Location
18.9
Actual Duration (Months)
1189
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a retrospective, researcher-initiated, database-based study that will retrospectively observe the treatment and medication patterns of about 22,500 patients with heart failure from 25 heart failure centers and 25 non-heart failure centers in the database of heart failure center. The proportion of patients with heart failure treatment drugs reaching the target dose recommended in the guidelines and discontinuation rate will be observed at 1 month, 3 months and 12 months follow up time point. The purpose of this study is to illustrate the current HF treatment status in HF center hospitals and non-HF center hospitals, which may provide insights for improving the clinical practice of heart failure treatment in China, and promote the standardization of heart failure treatment in China.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Actual Enrollment :
22500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China: a Retrospective Database-based Study
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Mar 31, 2023
Actual Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
HF center

heart failure patients enrolled from heart failure center hospitals

Other: no intervention
no intervention
non-HF center

heart failure patients enrolled from non-heart failure center hospitals

Outcome Measures

Primary Outcome Measures

  1. Number of GDMT drugs (classified as RAASi (including ARNI), beta blockers, MRA and SGLT2i) [At baseline and at 1 month, 3 month, 12 month follow-up time point]

    Numbers of GDMT drugs of HF patients stratified by HF ejection fraction and by HF Center and Non-HF Center

  2. Use rates of GDMT drugs [At baseline and at 1 month, 3 month, 12 month follow-up time point]

    The percentage of patients using each GDMT drug，stratified by HF ejection fraction and by HF Center and Non-HF Center

Secondary Outcome Measures

  1. The proportion of patients using 2 types of GDMT drugs [At baseline and at 1 month, 3 month, 12 month follow-up time point]

    The percentage of patients using 2 of any 4 GDMT drugs，stratified by HF ejection fraction and by HF Center and Non-HF Center

  2. The proportion of patients using 3 types of GDMT drugs [At baseline and at 1 month, 3 month, 12 month follow-up time point]

    The percentage of patients using 3 of any 4 GDMT drugs，stratified by HF ejection fraction and by HF Center and Non-HF Center

  3. The proportion of patients using 4 types of GDMT drugs [At baseline and at 1 month, 3 month, 12 month follow-up time point]

    The percentage of patients using all types of GDMT drugs，stratified by HF ejection fraction and by HF Center and Non-HF Center

  4. The proportion of patients with each GDMT drug in the target dose [at 1 month, 3 month, 12 month follow-up time point]

    The percentage of patients who achieved the target dose of each GDMT drug, stratified by HF ejection fraction and by HF Center and Non-HF Center

  5. Discontinuation rate of each GDMT drug [at 1 month, 3 month, 12 month follow-up time point]

    The percentage of patients who discontinued GDMT drugs, stratified by HF ejection fraction and by HF Center and Non-HF Center

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • An index HF diagnosis date in the records

  • Age ≥ 18 years old at initial diagnosis date

  • HF patients baseline characteristic record

Exclusion Criteria:
  • eGFR<30 ml/min/1.73m²

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiology, Peking University First Hospital Beijing China 100034

Sponsors and Collaborators

  • Peking University First Hospital
  • China Cardiovascular Association
  • AstraZeneca

Investigators

  • Principal Investigator: Huo Yong, MD., Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yong Huo, Prof, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT06099028
Other Study ID Numbers:
  • ESR-22-22035
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Oct 25, 2023