Effectiveness of Yiqi Fumai Lyophilized Injection for Acu... | NCT05586048

Studies
Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure

NCT05586048

Sponsor

China Academy of Chinese Medical Sciences

Status

Unknown status

Last Update Posted

Mar 10, 2023Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Acute Heart Failure
Complementary Medicine
Chinese Medicine

Interventions

Yiqi Fumai Lyophilized Injection(YQFM)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Estimated

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Nov 30, 2025Estimated

First Submitted Date

Oct 13, 2022

First Submission Date that Met QC Criteria

Oct 16, 2022

First Posted Date

Oct 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2023

Last Update Posted Date

Mar 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yan Liu, MD, Principal Investigator, China Academy of Chinese Medical SciencesPrincipal Investigator

Lead Sponsor

China Academy of Chinese Medical SciencesOTHER

Collaborators

Name	Class
National Natural Science Foundation of China	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exposed group		patients who received YQFM	Drug: Yiqi Fumai Lyophilized Injection(YQFM)
Non-exposed group		patients who didn't receive YQFM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yiqi Fumai Lyophilized Injection(YQFM)	Drug	No intervention was involved, but patients will be divided into exposed or non-exposed groups based on whether they received YQFM	Exposed group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
90-day all-cause mortality or readmission for HF	90-day all-cause mortality or readmission for HF	90-day

Secondary Outcomes

Measure	Description	Time Frame
180-day all-cause mortality or HF readmission	180-day all-cause mortality or HF readmission	180-day
cardiac-specific death	cardiac-specific death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with AHF in China

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan liu, Doctor	Contact	13811299493		sasliu@yeah.net

Overall Officials

Name	Affiliation	Role
Xuecheng Zhang, MD	Dongzhimen Hospital, Beijing	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongzhimen Hospital	Recruiting	Beijing	Beijing Municipality	100700	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32567238	Background	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.
36704479	Derived	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.