An observational study in Acute Heart Failure, Complementary Medicine and Chinese Medicine, sponsored by China Academy of Chinese Medical Sciences. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by China Academy of Chinese Medical Sciences · Observational
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.
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
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with AHF in China
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients who received YQFM
Drug: Yiqi Fumai Lyophilized Injection(YQFM)
patients who didn't receive YQFM
No intervention was involved, but patients will be divided into exposed or non-exposed groups based on whether they received YQFM
90-day all-cause mortality or readmission for HF
90-day all-cause mortality or readmission for HF
Time frame: 90-day
180-day all-cause mortality or HF readmission
180-day all-cause mortality or HF readmission
Time frame: 180-day
cardiac-specific death
cardiac-specific death
Time frame: 180 day
MACE
major cardiovascular adverse event
Time frame: 180 day
length of hospital stay
the length of patients staying in hospital
Time frame: 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.
Time frame: 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.
Time frame: during the hospitalization of patients, an average of 10 days
NYHA cardiac function classification
New York Heart Association cardiac function classification
Time frame: 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.
Time frame: 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
Time frame: 180 day
heart rate
heart rate
Time frame: 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
Time frame: at admission
Plan to share: Undecided
Start is estimated for Apr 2023; primary completion for Nov 2025, 31 months later.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 31 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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China Academy of Chinese Medical Sciences