Dilated CardiomyopathyPhase 4QLQX-DCMNCT01293903
Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy
A Phase 4 study testing Qiliqiangxin capsule in people with Dilated Cardiomyopathy and Heart Failure, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial… Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Dilated Cardiomyopathy, Heart Failure
- What is being tested?
- Qiliqiangxin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to 30 Sep 2016
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Dilated Cardiomyopathy (LVEF ≤ 45%)
Who cannot join
- Secondary dilated cardiomyopathy (such as ischemic cardiomyopathy, valvular cardiomyopathy, hyperthyroid cardiomyopathy, diabetic cardiomyopathy, anemia cardiomyopathy, and etc.)
- Coronary heart disease
- Rheumatic heart disease
- Pulmonary heart disease
- Continuous dysarteriotony: hypertension(systolic blood pressure [SBP] ≥ 60mmHg/diastolic blood pressure [DBP] ≥ 100mmHg); hypotension(SBP < 90mmHg/DBP < 60mmHg)
- Resting heart rate ≤ 50bpm
- Atrioventricular block patients without permanent pacemaker
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: A Multi-center, Randomized, Double, Placebo-controlled, Parallel Group Study of Improving Heart Function and Immunoregulation Effects of Qiliqiangxin Capsule in Patients With Dilated Cardiomyopathy
The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in patients with DCM, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo under the standard treatment of DCM.
- Conditions
- Dilated Cardiomyopathy, Heart Failure
- Being tested
- Qiliqiangxin capsule, Placebo
- Keywords
- Immunomodulation
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qiliqiangxin capsuleDrug
Qiliqiangxin capsule is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.
PlaceboDrug
Placebo, similar in color and taste to Qiliqiangxin capsule, is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.
| Study group | Role | What they receive |
|---|---|---|
| Qiliqiangxin capsule | Experimental | Not described Receives: Drug: Qiliqiangxin capsule |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)
Measured: 12 months after intervention
The levels of serum representative cytokines detected by ELISA
Measured: 12 months after intervention
Secondary outcomes (5)
Heart failure aggravation
Measured: 12 months after intervention
All cause mortality
Measured: 12 months after intervention
Sudden cardiac death
Measured: 12 months after intervention
Stroke
Measured: 12 months after intervention
The dynamic changes of serum representative cytokines detected by ELISA in the treatment group
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startJan 2012
- Primary completion31 Dec 2015
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital Xi'an Jiaotong University, Shandong Provincial Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Zhengzhou University, Ministry of Science and Technology of the People´s Republic of China, China National Center for Cardiovascular Diseases, RenJi Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Wuhan University, Henan Provincial People's Hospital, Jining Medical University, Second Hospital of Shanxi Medical University, Shanxi Cardiovascular Hospital, Wuhan Pu-Ai Hospital, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Yunyang Medical College, China Three Gorges University, Yichang, China, Xiangyang Central Hospital, Wuhan No.1 Hospital, Jingzhou Central Hospital
- Responsible party
- Principal investigator, Yu-Hua Liao, Huazhong University of Science and Technology
- Investigators
- Yu-Hua Liao, Docter, Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293903
- Sponsor's protocol ID
- QLQX-DCM-01
- Acronym
- QLQX-DCM
- Status last verified
- Aug 2017
- First submitted
- 31 Jan 2011
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang H, Zhong Y, Zhu Y, Zhao F, Cui X, Wang Z. Low responder T cell susceptibility to the suppressive function of regulatory T cells in patients with dilated cardiomyopathy. Heart. 2010 May;96(10):765-71. doi: 10.1136/hrt.2009.184945.
PubMed 20448127Yuan J, Yu M, Lin QW, Cao AL, Yu X, Dong JH, Wang JP, Zhang JH, Wang M, Guo HP, Cheng X, Liao YH. Th17 cells contribute to viral replication in coxsackievirus B3-induced acute viral myocarditis. J Immunol. 2010 Oct 1;185(7):4004-10. doi: 10.4049/jimmunol.1001718. Epub 2010 Aug 27.
PubMed 20802148Xiao H, Wang M, Du Y, Yuan J, Cheng X, Chen Z, Zou A, Wei F, Zhao G, Liao YH. Arrhythmogenic autoantibodies against calcium channel lead to sudden death in idiopathic dilated cardiomyopathy. Eur J Heart Fail. 2011 Mar;13(3):264-70. doi: 10.1093/eurjhf/hfq198. Epub 2010 Nov 2.
PubMed 21044990Xiao H, Song Y, Li Y, Liao YH, Chen J. Qiliqiangxin regulates the balance between tumor necrosis factor-alpha and interleukin-10 and improves cardiac function in rats with myocardial infarction. Cell Immunol. 2009;260(1):51-5. doi: 10.1016/j.cellimm.2009.09.001. Epub 2009 Sep 11.
PubMed 19833326
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double, Placebo-controlled, Parallel Group Study of Improving Heart Function and Immunoregulation Effects of Qiliqiangxin Capsule in Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01293903
- Acronym / sponsor ID
- QLQX-DCM / QLQX-DCM-01
- Conditions
- Dilated Cardiomyopathy, Heart Failure
- Keywords
- Immunomodulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Fudan University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital Xi'an Jiaotong University, Shandong Provincial Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Guangxi Medical University, The First Affiliated Hospital of Zhengzhou University, Ministry of Science and Technology of the People´s Republic of China, China National Center for Cardiovascular Diseases, RenJi Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Wuhan University, Henan Provincial People's Hospital, Jining Medical University, Second Hospital of Shanxi Medical University, Shanxi Cardiovascular Hospital, Wuhan Pu-Ai Hospital, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Yunyang Medical College, China Three Gorges University, Yichang, China, Xiangyang Central Hospital, Wuhan No.1 Hospital, Jingzhou Central Hospital
- Study start
- Jan 2012
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 11 Feb 2011 (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 pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in patients with DCM, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo under the standard treatment of DCM.
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 |
|---|---|---|
| Qiliqiangxin capsule | Experimental | Drug: Qiliqiangxin capsule |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Dilated Cardiomyopathy (LVEF ≤ 45%)
Key exclusion criteria (7 listed)
- Secondary dilated cardiomyopathy (such as ischemic cardiomyopathy, valvular cardiomyopathy, hyperthyroid cardiomyopathy, diabetic cardiomyopathy, anemia cardiomyopathy, and etc.)
- Coronary heart disease
- Rheumatic heart disease
- Pulmonary heart disease
- Continuous dysarteriotony: hypertension(systolic blood pressure [SBP] ≥ 60mmHg/diastolic blood pressure [DBP] ≥ 100mmHg); hypotension(SBP < 90mmHg/DBP < 60mmHg)
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 |
|---|---|---|
| Qiliqiangxin capsuleQiliqiangxin capsule is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period. | Drug | Qiliqiangxin capsule |
| PlaceboPlacebo, similar in color and taste to Qiliqiangxin capsule, is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period. | Drug | Placebo |
Primary outcome
The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG)
Time frame: 12 months after intervention
The levels of serum representative cytokines detected by ELISA
Time frame: 12 months after intervention
5 secondary outcomes
Heart failure aggravation
Time frame: 12 months after intervention
All cause mortality
Time frame: 12 months after intervention
Sudden cardiac death
Time frame: 12 months after intervention
Stroke
Time frame: 12 months after intervention
The dynamic changes of serum representative cytokines detected by ELISA in the treatment group
Time frame: 12 months after intervention
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 29 Aug 2017.
- Background: PubMed 20448127Tang H, Zhong Y, Zhu Y, Zhao F, Cui X, Wang Z. Low responder T cell susceptibility to the suppressive function of regulatory T cells in patients with dilated cardiomyopathy. Heart. 2010 May;96(10):765-71. doi: 10.1136/hrt.2009.184945.
- Background: PubMed 20802148Yuan J, Yu M, Lin QW, Cao AL, Yu X, Dong JH, Wang JP, Zhang JH, Wang M, Guo HP, Cheng X, Liao YH. Th17 cells contribute to viral replication in coxsackievirus B3-induced acute viral myocarditis. J Immunol. 2010 Oct 1;185(7):4004-10. doi: 10.4049/jimmunol.1001718. Epub 2010 Aug 27.
- Background: PubMed 21044990Xiao H, Wang M, Du Y, Yuan J, Cheng X, Chen Z, Zou A, Wei F, Zhao G, Liao YH. Arrhythmogenic autoantibodies against calcium channel lead to sudden death in idiopathic dilated cardiomyopathy. Eur J Heart Fail. 2011 Mar;13(3):264-70. doi: 10.1093/eurjhf/hfq198. Epub 2010 Nov 2.
- Background: PubMed 19833326Xiao H, Song Y, Li Y, Liao YH, Chen J. Qiliqiangxin regulates the balance between tumor necrosis factor-alpha and interleukin-10 and improves cardiac function in rats with myocardial infarction. Cell Immunol. 2009;260(1):51-5. doi: 10.1016/j.cellimm.2009.09.001. Epub 2009 Sep 11.
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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.
Yu-Hua Liao, Docter study chair
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qiliqiangxin capsule in people with Dilated Cardiomyopathy and Heart Failure, run by Huazhong University of Science and Technology at 1 site 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 1 inclusion and 7 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 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The value of left ventricular end-diastolic dimension (LVEDd) and left ventricular ejection fraction(LVEF) confirmed by ultrasonic cardiogram (UCG) (time frame: 12 months after intervention). The study lists 2 primary outcomes in all. 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 NCT01293903, which also lists 4 linked publications.
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 29 Aug 2017.