Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure

NCT05586048 | Unknown DMC

• 1 other identifier: AUGUST-AHF cohort
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Heart Failure; Complementary Medicine; Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 90-day all-cause mortality or readmission for HF

  90-day all-cause mortality or readmission for HF

  90-day

Secondary Outcomes (11)

• 180-day all-cause mortality or HF readmission

  180-day

• cardiac-specific death

  180 day

• MACE

  180 day

• length of hospital stay

  during the hospitalization of patients, an average of 10 days

• dyspnoea via visual analogue scale (VAS)

  during the hospitalization of patients, an average of 10 days

Study Arms (2)

Exposed group

patients who received YQFM

Drug: Yiqi Fumai Lyophilized Injection(YQFM)

Non-exposed group

patients who didn't receive YQFM

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AHF in China

You may qualify if:

• Diagnosis of AHF
• Age≥18 years
• Voluntarily participate in and sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• National Natural Science Foundation of China: collaborator

Study Sites (3)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

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

Guiyang, Guizhou, China

NOT YET RECRUITING

The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Guiyang, Guizhou, China

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 32567238 BACKGROUND

• 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.

  PMID: 36704479 DERIVED

Study Officials

• Xuecheng Zhang, MD

  Dongzhimen Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Yan liu, Doctor

CONTACT

13811299493; sasliu@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 19, 2022
• Study Start: April 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

CN (3)