Acute Heart FailurePhase 4NCT02135835
A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
A Phase 4 study testing Shenfu Zhusheye and 5% glucose injection in people with Acute Heart Failure, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. at 25 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Shenfu Zhusheye and 5% glucose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 365 participants
- Where
- 25 sitesChina
- Study dates
- 3 Sep 2014to 24 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Beijing Hospital
Beijing, 100730
Chinese PLA General Hospital
Beijing, 100853
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiangya Hospital Central South University
Changsha, Hunan, 410008
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Daqing peoples hospital
Daqing, Heilongjiang, 163000
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Tongde hospital of Zhejiang Province
Hangzhou, Zhejiang, 310012
An Hui Provincial Hospital
Hefei, Anhui, 230001
Hospital (T.C.M.) Affiliated to Sichuan Medical
Luzhou, Sichuan, 646000
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Nanshi Hospital of Nanyang
Nanyang, Henan, 473000
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, 200000
Shang Hai Chest Hospital Shanghai JiaoTong University
Shanghai, 200030
The Fouth Affiliated Hospital of China Mdical University
Shenyang, Liaoning, 110032
The People's Hospital of Liao Ning Province
Shenyang, Liaoning, 110032
The Fourth People's Hospital of Shenzhen（Futian Hospital）
Shenzhen, Guangdong, 518033
The First Affiliated Hospital of the Medical College,Shihezi University
Shihezi, XIjiangweiwuerzizhiqu, 832000
The First Affiliated Hospital of Xinjiang Medical
Ürümqi, Xinjiang, 830054
The Second Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiangweiwuerzizhiqu, 830000
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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.
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
- Conditions
- Acute Heart Failure
- Being tested
- Shenfu Zhusheye, 5% glucose injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenfu ZhusheyeDrug
5% glucose injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Shenfu Zhusheye | Experimental | 80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days. Receives: Drug: Shenfu Zhusheye; Drug: 5% glucose injection |
| 5% glucose injection | Placebo comparator | 150 ml 5% glucose injection, ivdrip, once a day for 7 days. Receives: Drug: 5% glucose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
Measured: 0, 7 days
Secondary outcomes (7)
Decrease rate in NT-proBNP compared to pre-treatment.
Measured: 0, 7 days.
Decrease value in NT-proBNP compared to pre-treatment.
Measured: 0, 7 days.
Likert rating scale of Dyspnoea.
Measured: 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.
Measured: 0, 7 days.
Heart function grade of NYHA.
Measured: 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.
Measured: 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.
Measured: Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start3 Sep 2014
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiefu Yang, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135835
- Sponsor's protocol ID
- 1312-Z-SHFU-ZS-RE
- Status last verified
- Jan 2018
- First submitted
- 22 Apr 2014
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02135835
- Acronym / sponsor ID
- 1312-Z-SHFU-ZS-RE
- Conditions
- Acute Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2014 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shenfu Zhusheye | Experimental | Drug: Shenfu Zhusheye, Drug: 5% glucose injection80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days. |
| 5% glucose injection | Placebo comparator | Drug: 5% glucose injection150 ml 5% glucose injection, ivdrip, once a day for 7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shenfu Zhusheye | Drug | Shenfu Zhusheye |
| 5% glucose injection | Drug | 5% glucose injection, Shenfu Zhusheye |
Primary outcome
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
Time frame: 0, 7 days
7 secondary outcomes
Decrease rate in NT-proBNP compared to pre-treatment.
Time frame: 0, 7 days.
Decrease value in NT-proBNP compared to pre-treatment.
Time frame: 0, 7 days.
Likert rating scale of Dyspnoea.
Time frame: 0, 7 days.
The results of Transthoracic Doppler-echocardiography .
Time frame: 0, 7 days.
Heart function grade of NYHA.
Time frame: 0, 7 days.
Composite endpoints.
Time frame: 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.
Time frame: Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiefu Yang principal investigator
Beijing Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shenfu Zhusheye and 5% glucose injection in people with Acute Heart Failure, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. at 25 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment. (time frame: 0, 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.