A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.

Official Title
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A Multicentre, Parallel-Group, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure.

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Drug: Shenfu Zhusheye
* Drug: 5% glucose injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shenfu Zhusheye<br>80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days. | Drug: Shenfu Zhusheye<br> <br> Drug: 5% glucose injection<br> <br> |
| Placebo Comparator: 5% glucose injection<br>150 ml 5% glucose injection, ivdrip, once a day for 7 days. | Drug: 5% glucose injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment. |  | 0, 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease rate in NT-proBNP compared to pre-treatment. |  | 0, 7 days. | 
| 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 . | Left ventricular ejection fraction (LVEF) and Left Ventricular Diastolic End Diameter (LVDED) will be measured with Transthoracic Doppler-echocardiography. | 0, 7 days. | 
| Heart function grade of NYHA. |  | 0, 7 days. | 
| Composite endpoints. | 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. | Composite endpoints will be assessed during medication period and 28 days after medication. | 
| 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. |