Acute Heart Failure
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
Interventions
DRUGShenfu Zhusheye
Sponsors
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Acute Heart Failure according to Guidelines for the diagnosis and treatment of acute heart failure 2010 of Chinese Medical Association(Participants whose Heart function grade of NYHA is Ⅲ～Ⅳ). * LVEF≤40%. * NT-pro-BNP ≥1400 pg/mL or BNP ≥ 350pg/mL. * Ages 18-80, male or female. * All participants signed the informed consent.
Exclusion criteria
* Participants with abnormal liver function (ALT, AST≥3 times of upper limit of normal) or abnormal kidney function( Cr≥1.5 times of upper limit of normal or Cr \>3.0 mg/dl (\> 265 µmol/L)). * SBP ≥ 150mmHg. * Participants with severe chronic asthmatic bronchitis or acute episode of lung diseases. * Participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery. * Participants with advanced cancer. * Breastfeeding, pregnant and potentially fertile women participant. * Participants with insanity. * Known allergies with Shenfu Zhusheye or its ingredients in the past. * Participants who have taken part in other clinical trials in last month. * Participants who abuse alcohol or other drugs in last year. * Participants who are not suitable for clinical trial under doctors' consideration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment. | 0, 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease value in NT-proBNP compared to pre-treatment. | 0, 7 days. | — |
| Likert rating scale of Dyspnoea. | 0, 7 days. | — |
| The results of Transthoracic Doppler-echocardiography . | 0, 7 days. | Left ventricular ejection fraction (LVEF) and Left Ventricular Diastolic End Diameter (LVDED) will be measured with Transthoracic Doppler-echocardiography. |
| Decrease rate in NT-proBNP compared to pre-treatment. | 0, 7 days. | — |
| Composite endpoints. | Composite endpoints will be assessed during medication period and 28 days after medication. | Composite endpoints were defined as death, cardiac arrest with resuscitation, readmission for heart failure, worsening heart failure with an intravenous pharmacologic agent for more than 4 hours, stroke or cases where the patient ceased active treatments because of worsening heart failure. |
| Safety assessments will be based on adverse event reports and the results of clinical laboratory tests, electrocardiogram. | Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days. | — |
| Heart function grade of NYHA. | 0, 7 days. | — |
Countries
China
Outcome results
None listed