Acute Heart FailureAUGUST-AHFNCT05586048
Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure
An observational study of Acute Heart Failure and Complementary Medicine, run by China Academy of Chinese Medical Sciences at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Complementary Medicine, Chinese Medicine
- What is being tested?
- Yiqi Fumai Lyophilized Injection(YQFM)
- Type of treatment
- Injection or infusion
- How many people
- 1,200 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AHF in China
Who may be able to join
- Diagnosis of AHF
- Age≥18 years
- Voluntarily participate in and sign the informed consent form
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Yan Liu, Doctor, sasliu@yeah.net
Xuecheng Zhang, Doctor, zhangxuechengmail@163.com
- Not yet recruiting
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang
Guiyang, Guizhou
Zhenghuan Li, 18185152056
- Not yet recruiting
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Guiyang, Guizhou
Tao Xv, 15985015270
About this study
Official title: Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure: AUGUST-AHF Cohort Study
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.
Read the 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
- Being tested
- Yiqi Fumai Lyophilized Injection(YQFM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | patients who received YQFM Receives: Drug: Yiqi Fumai Lyophilized Injection(YQFM) | |
| Non-exposed group | patients who didn't receive YQFM |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day all-cause mortality or readmission for HF
90-day all-cause mortality or readmission for HF
Measured: 90-day
Secondary outcomes (11)
180-day all-cause mortality or HF readmission
180-day all-cause mortality or HF readmission
Measured: 180-day
cardiac-specific death
cardiac-specific death
Measured: 180 day
MACE
major cardiovascular adverse event
Measured: 180 day
length of hospital stay
the length of patients staying in hospital
Measured: during the hospitalization of patients, an average of 10 days
dyspnoea via visual analogue scale (VAS)
Dyspnea VAS scores range from a maximum of 10 to a minimum of 0. Higher scores mean a worse outcome. 10 means extreme dyspnea, and 0 means no dyspnea.
Measured: during the hospitalization of patients, an average of 10 days
dyspnoea via Likert 7-point scale
The Likert 7-point scores range from a maximum of 7 to a minimum of 1. Higher scores mean a better outcome.
Measured: during the hospitalization of patients, an average of 10 days
NYHA cardiac function classification
New York Heart Association cardiac function classification
Measured: 180 day
Minnesota Living with Heart Failure Quality of Life (MLHFQ) scale
Likert 7-point scores range from a maximum of 105 to a minimum of 0. Higher scores mean a worse outcome.
Measured: 180 day
Morisky Medication Adherence Scale (MMAS)-8 scale
MMAS-8 scores range from a maximum of 8 to a minimum of 0. Higher scores mean a better outcome
Measured: 180 day
heart rate
heart rate
Measured: 180 day
number of participants eligible for the randomized controlled trial of AUGUST-AHF
Patients will complete a questionnaire with the help of researchers. This questionnaire includes the inclusion criteria for another study, the randomized controlled trial of AUGUST-AHF. After the patient has completed the questionnaire, the investigator will determine whether the patient meets the criteria based on the results
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Apr 2023 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Yan Liu, MD, China Academy of Chinese Medical Sciences
- Investigators
- Xuecheng Zhang, MD, Study director, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586048
- Sponsor's protocol ID
- AUGUST-AHF cohort
- Acronym
- AUGUST-AHF
- Status last verified
- Mar 2023
- First submitted
- 13 Oct 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32567238Zhang 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.
PubMed 36704479
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure: AUGUST-AHF Cohort Study
- ClinicalTrials.gov ID
- NCT05586048
- Acronym / sponsor ID
- AUGUST-AHF / AUGUST-AHF cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: Yiqi Fumai Lyophilized Injection(YQFM)patients who received YQFM |
| Non-exposed group | – | –patients who didn't receive YQFM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AHF in China
Key inclusion criteria (3 listed)
- Diagnosis of AHF
- Age≥18 years
- Voluntarily participate in and sign the informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Exposed group |
Primary outcome
90-day all-cause mortality or readmission for HF
Time frame: 90-day
90-day all-cause mortality or readmission for HF
11 secondary outcomes
180-day all-cause mortality or HF readmission
Time frame: 180-day
cardiac-specific death
Time frame: 180 day
MACE
Time frame: 180 day
length of hospital stay
Time frame: during the hospitalization of patients, an average of 10 days
dyspnoea via visual analogue scale (VAS)
Time frame: during the hospitalization of patients, an average of 10 days
dyspnoea via Likert 7-point scale
Time frame: during the hospitalization of patients, an average of 10 days
NYHA cardiac function classification
Time frame: 180 day
Minnesota Living with Heart Failure Quality of Life (MLHFQ) scale
Time frame: 180 day
Morisky Medication Adherence Scale (MMAS)-8 scale
Time frame: 180 day
heart rate
Time frame: 180 day
number of participants eligible for the randomized controlled trial of AUGUST-AHF
Time frame: at admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 32567238Zhang 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.
- Derived from this study: PubMed 36704479Zhang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuecheng Zhang, MD study director
Dongzhimen Hospital, Beijing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and Complementary Medicine, run by China Academy of Chinese Medical Sciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan liu, Doctor (13811299493, sasliu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day all-cause mortality or readmission for HF (time frame: 90-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05586048, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.