Trial | NCT02135835  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    365
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
Study Started
Sep 03
2014
Primary Completion
Mar 24
2017
Study Completion
Mar 24
2017
Last Update
Mar 01
2018

Drug Shenfu Zhusheye

Drug 5% glucose injection

5% glucose injection Placebo Comparator

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

Shenfu Zhusheye Experimental

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

Criteria 

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.
No Results Posted