Clinical trial NCT02135835: A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
Official title: A Multicentre, Parallel-Group, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Heart Failure
Lead sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
timeFrame: 0, 7 days
Secondary outcomes:
measure: Decrease rate in NT-proBNP compared to pre-treatment.
timeFrame: 0, 7 days.
measure: Decrease value in NT-proBNP compared to pre-treatment.
timeFrame: 0, 7 days.
measure: Likert rating scale of Dyspnoea.
timeFrame: 0, 7 days.
measure: The results of Transthoracic Doppler-echocardiography .
timeFrame: 0, 7 days.
measure: Heart function grade of NYHA.
timeFrame: 0, 7 days.
measure: Composite endpoints.
timeFrame: Composite endpoints will be assessed during medication period and 28 days after medication.
measure: Safety assessments will be based on adverse event reports and the results of clinical laboratory tests, electrocardiogram.
timeFrame: Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days.
Other outcomes:
Locations:
city: Hefei
country: China
facility: An Hui Provincial Hospital
state: Anhui
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: The Fourth People's Hospital of Shenzhen（Futian Hospital）
state: Guangdong
city: Daqing
country: China
facility: Daqing peoples hospital
state: Heilongjiang
city: Nanyang
country: China
facility: Nanshi Hospital of Nanyang
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The Fouth Affiliated Hospital of China Mdical University
state: Liaoning
city: Shenyang
country: China
facility: The People's Hospital of Liao Ning Province
state: Liaoning
city: Shanghai
country: China
facility: Tongren Hospital Shanghai Jiao Tong University School Of Medicine
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital Of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Luzhou
country: China
facility: Hospital (T.C.M.) Affiliated to Sichuan Medical
state: Sichuan
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
state: Sichuan
city: Shihezi
country: China
facility: The First Affiliated Hospital of the Medical College,Shihezi University
state: XIjiangweiwuerzizhiqu
city: Ürümqi
country: China
facility: The Second Affiliated Hospital of Xinjiang Medical University
state: Xinjiangweiwuerzizhiqu
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical
state: Xinjiang
city: Hangzhou
country: China
facility: Tongde hospital of Zhejiang Province
state: Zhejiang
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Shanghai
country: China
facility: Shang Hai Chest Hospital Shanghai JiaoTong University
Study officials:
affiliation: Beijing Hospital
name: Jiefu Yang
role: PRINCIPAL_INVESTIGATOR
References: