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

Acute Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135835
• Other study ID #: 1312-Z-SHFU-ZS-RE
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2014
• Last updated: February 27, 2018
• Start date: September 3, 2014
• Est. completion date: March 24, 2017

Study information

• Verified date: January 2018
• Source: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: March 24, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?~?).

• 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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Drug:
• Shenfu Zhusheye

• 5% glucose injection

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Chinese PLA General Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Daqing peoples hospital	Daqing	Heilongjiang
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Tongde hospital of Zhejiang Province	Hangzhou	Zhejiang
China	An Hui Provincial Hospital	Hefei	Anhui
China	Hospital (T.C.M.) Affiliated to Sichuan Medical	Luzhou	Sichuan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Nanshi Hospital of Nanyang	Nanyang	Henan
China	Shang Hai Chest Hospital Shanghai JiaoTong University	Shanghai
China	Tongren Hospital Shanghai Jiao Tong University School Of Medicine	Shanghai	Shanghai
China	The Fouth Affiliated Hospital of China Mdical University	Shenyang	Liaoning
China	The People's Hospital of Liao Ning Province	Shenyang	Liaoning
China	The Fourth People's Hospital of Shenzhen(Futian Hospital)	Shenzhen	Guangdong
China	The First Affiliated Hospital of the Medical College,Shihezi University	Shihezi	XIjiangweiwuerzizhiqu
China	The First Affiliated Hospital of Xinjiang Medical	Urumqi	Xinjiang
China	The Second Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiangweiwuerzizhiqu
China	The First Affiliated Hospital Of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	The Second People's Hospital of Yibin	Yibin	Sichuan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.		0, 7 days
Secondary	Decrease rate in NT-proBNP compared to pre-treatment.		0, 7 days.
Secondary	Decrease value in NT-proBNP compared to pre-treatment.		0, 7 days.
Secondary	Likert rating scale of Dyspnoea.		0, 7 days.
Secondary	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.
Secondary	Heart function grade of NYHA.		0, 7 days.
Secondary	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.
Secondary	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.