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

January 21, 2024 updated by: Yong Huo, Peking University First Hospital

Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China: a Retrospective Database-based Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • Department of Cardiology, Peking University First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include HF patients extracted from the HF centers Database. The enrolment of HF cases was via the consecutive sampling. In this study, the study time frame is from 2021.09 to 2023.03. The index date will be defined as the discharge date after the first HF admission (inpatient) record shown in the database, (i.e., the discharge date is the date entry into the HF centers Database). Given that previous treatment condition of these patients before the enrolment in this database is unknown, the baseline information was only collected at the index date. Patient follow-ups were scheduled at 1 month, 3 months and 12 months after the first discharge. The window of follow-up was set for ±14 days.

Description

Inclusion Criteria:

  • An index HF diagnosis date in the records
  • Age ≥ 18 years old at initial diagnosis date
  • HF patients baseline characteristic record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of GDMT drugs (classified as RAASi (including ARNI), beta blockers, MRA and SGLT2i)
Time Frame: 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
At baseline and at 1 month, 3 month, 12 month follow-up time point
Use rates of GDMT drugs
Time Frame: 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
At baseline and at 1 month, 3 month, 12 month follow-up time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients using 2 types of GDMT drugs
Time Frame: 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
At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients using 3 types of GDMT drugs
Time Frame: 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
At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients using 4 types of GDMT drugs
Time Frame: 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
At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients with each GDMT drug in the target dose
Time Frame: 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
at 1 month, 3 month, 12 month follow-up time point
Discontinuation rate of each GDMT drug
Time Frame: 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
at 1 month, 3 month, 12 month follow-up time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

AstraZeneca
China Cardiovascular Association

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-22-22035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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