Left Ventricular RemodelingPhase 4NCT02675322
Danlou Tablets to Prevent Left Ventricular Remodeling
A Phase 4 study testing Danlou Tablets in people with Left Ventricular Remodeling and Acute Myocardial Infarction, run by shuai Mao.
Trial summary
Danlou tablets are Chinese patent medicine which has been approved in China for the treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Left Ventricular Remodeling, Acute Myocardial Infarction
- What is being tested?
- Danlou Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2015
- 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
- acute myocardial infarction
- successfully underwent revascularization
Who cannot join
- previous myocardial infarction within 30 days
- malignant arrhythmia
- congenital heart disease
- cardiac shock
- documented or suspected history of heart failure or depressed LV ejection fraction <15%
- planned coronary artery bypass grafting
Show all 12Show fewer
- a life expectancy of <1 year
- hepatic impairment
- glomerular filtration rate ≤30 mL/min per 1.73 m2
- autoimmune or connective tissue disease
- chronic substance abuse or psychiatric illness
- unable to complete 3 month clinical follow-up
About this study
Official title: Effects of Danlou Tablets to Prevent Left Ventricular Remodeling After Myocardial Infarction: A Double-blind, Randomized, Placebo Controlled, Pilot Study
Danlou tablets are Chinese patent medicine which has been approved in China for the treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling remains unclear. This pilot study was designed to determine whether Danlou tablets reduced adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI). Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI. Major end points were changes in LV volumes and ejection fractions as evaluated by serial echocardiography in addition to clinical outcomes were also determined.
Read the detailed description
This randomized, prospective, double-blind, placebo-controlled, parallel-group clinical trial was performed in two institutions (Guangdong Provincial Hospital of CM and Wuyi Hospital of CM). The study was conducted in accordance with the Declaration of Helsinki and its text revisions and all participants provided written informed consent before enrollment. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (B2011-41-01).
Once eligible candidates had undergone PCI, they were admitted to the coronary intensive care unit and received standard treatment according to the institutional protocol based on American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines.20 Simultaneously, patients were randomized assigned in a 1:1 ratio to receive Danlou tablets (4.5 g oral dose taken once daily) or matching placebo for 90 days according to a computer-generated site-stratified, block randomization schedule. Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
- Being tested
- Danlou Tablets, Placebo
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danlou TabletsDrug
Also called Danlou
Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
PlaceboOther
Placebo with no chemical effects.
| Study group | Role | What they receive |
|---|---|---|
| Danlou Tablets | Experimental | Danlou tablets (4.5 g oral dose taken once daily) for 90 days Receives: Drug: Danlou Tablets |
| placebo | Placebo comparator | matching placebo for 90 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days
Left Ventricular End Diastolic Volume Index (LVEDVi) measured by two-dimensional echocardiography.
Measured: 90 days
Secondary outcomes (4)
changes in Left ventricular End Systolic Volume Index from baseline to 90 days
Left Ventricular End Systolic Volume Index (LVESVi) measured by two-dimensional echocardiography.
Measured: 90 days
Major adverse cardiovascular events
Major adverse cardiovascular events includes cardiac death, cardiac shock, myocardial infarction, documented unstable angina requiring revascularization (bypass surgery or repeat PCI), severe angina or severe heart failure.
Measured: 90 days
adverse events
Measured: 180 days
Left ventricular Ejection Fraction from baseline to 90 days
Left ventricular Ejection Fraction (LVEF) measured by two-dimensional echocardiography.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular RemodelingStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- shuai Mao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, shuai Mao, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- minzhou zhang, M.D., Study chair, Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675322
- Sponsor's protocol ID
- GuangdongPHTCM
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2016
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mao S, Wang L, Ouyang W, Zhou Y, Qi J, Guo L, Zhang M, Hinek A. Traditional Chinese medicine, Danlou tablets alleviate adverse left ventricular remodeling after myocardial infarction: results of a double-blind, randomized, placebo-controlled, pilot study. BMC Complement Altern Med. 2016 Nov 8;16(1):447. doi: 10.1186/s12906-016-1406-4.
PubMed 27825334
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Danlou Tablets to Prevent Left Ventricular Remodeling After Myocardial Infarction: A Double-blind, Randomized, Placebo Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT02675322
- Acronym / sponsor ID
- GuangdongPHTCM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- shuai MaoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Feb 2016 (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.
Danlou tablets are Chinese patent medicine which has been approved in China for the treatment of ischemic heart disease, but the evidence supporting its efficacy on cardiac remodeling remains unclear. This pilot study was designed to determine whether Danlou tablets reduced adverse left ventricular (LV) remodeling in patients with acute myocardial infarction (MI). Patients following acute MI were enrolled and randomly allocated to Danlou tablets (4.5 g q.d. for 90 days) or placebo, superimposed on standard medications for the treatment of MI. Major end points were changes in LV volumes and ejection fractions as evaluated by serial echocardiography in addition to clinical outcomes were also determined.
Detailed description
This randomized, prospective, double-blind, placebo-controlled, parallel-group clinical trial was performed in two institutions (Guangdong Provincial Hospital of CM and Wuyi Hospital of CM). The study was conducted in accordance with the Declaration of Helsinki and its text revisions and all participants provided written informed consent before enrollment. The Clinical Research Ethical Committee at Guangdong Provincial Hospital of Chinese Medicine approved the research protocol (B2011-41-01).
Once eligible candidates had undergone PCI, they were admitted to the coronary intensive care unit and received standard treatment according to the institutional protocol based on American College of Cardiology/ American Heart Association and European Society of Cardiology guidelines.20 Simultaneously, patients were randomized assigned in a 1:1 ratio to receive Danlou tablets (4.5 g oral dose taken once daily) or matching placebo for 90 days according to a computer-generated site-stratified, block randomization schedule. Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Danlou Tablets | Experimental | Drug: Danlou TabletsDanlou tablets (4.5 g oral dose taken once daily) for 90 days |
| placebo | Placebo comparator | Other: Placebomatching placebo for 90 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute myocardial infarction
- successfully underwent revascularization
Key exclusion criteria (12 listed)
- previous myocardial infarction within 30 days
- malignant arrhythmia
- congenital heart disease
- cardiac shock
- documented or suspected history of heart failure or depressed LV ejection fraction <15%
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 |
|---|---|---|
| Danlou TabletsAlso: DanlouDanlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244). | Drug | Danlou Tablets |
| PlaceboPlacebo with no chemical effects. | Other | placebo |
Primary outcome
change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days
Time frame: 90 days
Left Ventricular End Diastolic Volume Index (LVEDVi) measured by two-dimensional echocardiography.
4 secondary outcomes
changes in Left ventricular End Systolic Volume Index from baseline to 90 days
Time frame: 90 days
Major adverse cardiovascular events
Time frame: 90 days
adverse events
Time frame: 180 days
Left ventricular Ejection Fraction from baseline to 90 days
Time frame: 90 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 5 Feb 2016.
- Derived from this study: PubMed 27825334Mao S, Wang L, Ouyang W, Zhou Y, Qi J, Guo L, Zhang M, Hinek A. Traditional Chinese medicine, Danlou tablets alleviate adverse left ventricular remodeling after myocardial infarction: results of a double-blind, randomized, placebo-controlled, pilot study. BMC Complement Altern Med. 2016 Nov 8;16(1):447. doi: 10.1186/s12906-016-1406-4.
- Individual participant dataSharing planned: No
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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.
minzhou zhang, M.D. study chair
Heart Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Danlou Tablets in people with Left Ventricular Remodeling and Acute Myocardial Infarction, run by shuai Mao.
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 2 inclusion and 12 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 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
change in the Left Ventricular End Diastolic Volume Index from baseline to 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675322, which also lists 1 linked publication.
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 5 Feb 2016.