Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure

NCT ID: NCT05586048

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-11-30

Brief Summary

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The goal of this cohort study is to observe the effectiveness of Yiqi Fumai Lyophilized Injection (YQFM) in patients with acute heart failure (AHF). It mainly aims to assess the effectiveness of YQFM on the 90-day mortality or readmission rate in patients with AHF and compare the results with AUGUST-AHF RCT study. There will be no intervention, but information will be collected during the hospital stay and during the follow-up period of 180 days . Researchers will compare exposed group(patients who received YQFM) and non-exposed group(patients who didn't received YQFM) to see if there is difference on the 90-day mortality or readmission rate.

Detailed Description

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It mainly aims to assess the effectiveness of YQFM on the 90-day mortality or readmission rate in patients with AHF and compare the results with AUGUST-AHF RCT study. There will be no intervention, but patients will be asked to answer questions(such as scales or reporting of symptoms ) and provide biochemical or imaging tests, as well as undergo regular follow-up. Researchers will compare exposed group(patients who received YQFM) and non-exposed group(patients who didn't received YQFM) to see if there is difference on the 90-day mortality or readmission rate. We will also collect information on medication adherence during the follow-up period and remotely test patients during the follow-up period

Conditions

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Acute Heart Failure Complementary Medicine Chinese Medicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed group

patients who received YQFM

Yiqi Fumai Lyophilized Injection(YQFM)

Intervention Type DRUG

No intervention was involved, but patients will be divided into exposed or non-exposed groups based on whether they received YQFM

Non-exposed group

patients who didn't receive YQFM

No interventions assigned to this group

Interventions

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Yiqi Fumai Lyophilized Injection(YQFM)

No intervention was involved, but patients will be divided into exposed or non-exposed groups based on whether they received YQFM

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of AHF
* Age≄18 years
* Voluntarily participate in and sign the informed consent form

Exclusion Criteria

* With major psychiatric disorders or unable to complete follow-up assessment
* Known allergies to drugs or drug ingredients
* Patients enrolled in other trials within 1 month
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yan Liu, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuecheng Zhang, MD

Role: STUDY_DIRECTOR

Dongzhimen Hospital, Beijing

Locations

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Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang

Guiyang, Guizhou, China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guiyang, Guizhou, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Yan liu, Doctor

Role: CONTACT

13811299493

Facility Contacts

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Yan Liu, Doctor

Role: primary

Xuecheng Zhang, Doctor

Role: backup

Zhenghuan Li

Role: primary

18185152056

Tao Xv

Role: primary

15985015270

References

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Zhang J, Sun Y, Zhou K, Zhang X, Chen Y, Hu J, Zhong C, Liu Y, Shang H. Rationale and design of the AUGUST-AHF Study. ESC Heart Fail. 2020 Oct;7(5):3124-3133. doi: 10.1002/ehf2.12787. Epub 2020 Jun 22.

Reference Type BACKGROUND
PMID: 32567238 (View on PubMed)

Zhang X, Kang J, Zhang J, Chen Y, Dai H, Hu M, Liu Y, Shang H. Effectiveness of Yiqi Fumai lyophilized injection for acute heart failure: Rationale and design of the AUGUST-AHF cohort study. Front Cardiovasc Med. 2023 Jan 10;9:1074406. doi: 10.3389/fcvm.2022.1074406. eCollection 2022.

Reference Type DERIVED
PMID: 36704479 (View on PubMed)

Other Identifiers

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AUGUST-AHF cohort

Identifier Type: -

Identifier Source: org_study_id

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