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

China Resources Sanjiu Medical & Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Acute Heart Failure

Treatments: Drug: Shenfu Zhusheye; Drug: 5% glucose injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02135835

1312-Z-SHFU-ZS-RE

Details and patient eligibility

About

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

Enrollment: 365 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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365 participants in 2 patient groups, including a placebo group

Shenfu Zhusheye

Experimental group

Description:

80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.

Treatment:

Drug: 5% glucose injection

Drug: Shenfu Zhusheye

5% glucose injection

Placebo Comparator group

Description:

150 ml 5% glucose injection, ivdrip, once a day for 7 days.

Treatment:

Drug: 5% glucose injection