Cardiovascular DiseasePhase 4NCT02797028
Investigation of the Atherogenic Effects of Uric Acid-modified in Endothelial Dysfunction and the the Preventional Mechanism by Anthocyanidines
A Phase 4 study testing Anthocyanidins capsule and Allopurinol in people with Cardiovascular Disease, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Anthocyanidins capsule and Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Serum uric acid >420μmol/L (7mg/dL) in male, >360μmol/L (6mg/dL) in female identified as hyperuricemia patients.
Who cannot join
- Age more than 60 years and less than 30 years old;
- acute infection, tumor, recent surgery, need for hemodialysis and autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Guangzhou Military Command of People's Liberation Army
Guangzhou, Guangdong, 020
Hui Dai, 020-36653321, daihui66@sina.com
Yuan Zhang, 020-61653566, 1035834805@qq.com
About this study
The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.
Read the detailed description
Hyperuricemia patients who have the ability to complete the intervention study in the early stage of study were selected as the research subjects. A randomized controlled double blind control method was used to study the effect of one year of anthocyanins intervention. Serum UA levels, oxidative stress, AGEs, and endothelial function are detecting in patients with hyperuricemia who were treated with anthocyanins and placebo. Providing scientific basis of anthocyanins for the treatment with hyperuricemia and delaying atherosclerosis.
- Conditions
- Cardiovascular Disease
- Being tested
- Anthocyanidins capsule, Placebo capsule, Allopurinol
- Keywords
- Hyperuricemia, endothelial function, anthocyanidins
- Medical subject headings
- Cardiovascular Diseases, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyanidins capsuleDietary supplement
Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
Placebo capsuleDietary supplement
Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
AllopurinolDrug
Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsule | Placebo comparator | Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule Receives: Dietary Supplement: Placebo capsule |
| Anthocyanidins capsule | Experimental | Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule. Receives: Dietary Supplement: Anthocyanidins capsule |
| Allopurinol | Experimental | The experimental group taking allopurinol. Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of serum uric acid levels in all patients
Serum uric acid (mg/dl) is determined by Uric Acid kit on an automated system.
Measured: up to 1 months
Secondary outcomes (1)
Measurement of advanced glycation end products and its receptor level in all patients
Advanced glycation end products and its receptor level are determined by high efficiency liquid chromatography.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Principal investigator, Yuan Zhang, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797028
- Sponsor's protocol ID
- No. 81402671
- Status last verified
- Jun 2016
- First submitted
- 12 May 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.
PubMed 15198963Gimbrone MA Jr. Endothelial dysfunction and atherosclerosis. J Card Surg. 1989 Jun;4(2):180-3. doi: 10.1111/j.1540-8191.1989.tb00275.x.
PubMed 2519996Verma S, Anderson TJ. Fundamentals of endothelial function for the clinical cardiologist. Circulation. 2002 Feb 5;105(5):546-9. doi: 10.1161/hc0502.104540. No abstract available.
PubMed 11827916D'Marco L, Garcia I, Vega C. [Uric acid, atherosclerosis and vascular calcifications in chronic kidney disease]. Invest Clin. 2012 Mar;53(1):52-9. Spanish.
PubMed 22524108Feig DI, Kang DH, Johnson RJ. Uric acid and cardiovascular risk. N Engl J Med. 2008 Oct 23;359(17):1811-21. doi: 10.1056/NEJMra0800885. No abstract available.
PubMed 18946066Li C, Han L, Levin AM, Song H, Yan S, Wang Y, Wang Y, Meng D, Lv S, Ji Y, Xu X, Liu X, Wang Y, Zhou L, Miao Z, Mi QS. Multiple single nucleotide polymorphisms in the human urate transporter 1 (hURAT1) gene are associated with hyperuricaemia in Han Chinese. J Med Genet. 2010 Mar;47(3):204-10. doi: 10.1136/jmg.2009.068619. Epub 2009 Oct 14.
PubMed 19833602
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Atherogenic Effects of Uric Acid-modified in Endothelial Dysfunction and the the Preventional Mechanism by Anthocyanidines
- ClinicalTrials.gov ID
- NCT02797028
- Acronym / sponsor ID
- No. 81402671
- Conditions
- Cardiovascular Disease
- Keywords
- Hyperuricemia, endothelial function, anthocyanidins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Jan 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Jun 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.
The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.
Detailed description
Hyperuricemia patients who have the ability to complete the intervention study in the early stage of study were selected as the research subjects. A randomized controlled double blind control method was used to study the effect of one year of anthocyanins intervention. Serum UA levels, oxidative stress, AGEs, and endothelial function are detecting in patients with hyperuricemia who were treated with anthocyanins and placebo. Providing scientific basis of anthocyanins for the treatment with hyperuricemia and delaying atherosclerosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo capsuleSimple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule |
| Anthocyanidins capsule | Experimental | Dietary Supplement: Anthocyanidins capsuleSimple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule. |
| Allopurinol | Experimental | Drug: AllopurinolThe experimental group taking allopurinol. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Serum uric acid >420μmol/L (7mg/dL) in male, >360μmol/L (6mg/dL) in female identified as hyperuricemia patients.
Key exclusion criteria (2 listed)
- Age more than 60 years and less than 30 years old;
- acute infection, tumor, recent surgery, need for hemodialysis and autoimmune diseases.
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 |
|---|---|---|
| Anthocyanidins capsuleContinuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months | Dietary supplement | Anthocyanidins capsule |
| Placebo capsuleContinuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months | Dietary supplement | Placebo capsule |
| AllopurinolContinuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months | Drug | Allopurinol |
Primary outcome
Measurement of serum uric acid levels in all patients
Time frame: up to 1 months
Serum uric acid (mg/dl) is determined by Uric Acid kit on an automated system.
1 secondary outcome
Measurement of advanced glycation end products and its receptor level in all patients
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Background: PubMed 15198963Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.
- Background: PubMed 2519996Gimbrone MA Jr. Endothelial dysfunction and atherosclerosis. J Card Surg. 1989 Jun;4(2):180-3. doi: 10.1111/j.1540-8191.1989.tb00275.x.
- Background: PubMed 11827916Verma S, Anderson TJ. Fundamentals of endothelial function for the clinical cardiologist. Circulation. 2002 Feb 5;105(5):546-9. doi: 10.1161/hc0502.104540. No abstract available.
- Background: PubMed 22524108D'Marco L, Garcia I, Vega C. [Uric acid, atherosclerosis and vascular calcifications in chronic kidney disease]. Invest Clin. 2012 Mar;53(1):52-9. Spanish.
- Background: PubMed 18946066Feig DI, Kang DH, Johnson RJ. Uric acid and cardiovascular risk. N Engl J Med. 2008 Oct 23;359(17):1811-21. doi: 10.1056/NEJMra0800885. No abstract available.
- Background: PubMed 19833602Li C, Han L, Levin AM, Song H, Yan S, Wang Y, Wang Y, Meng D, Lv S, Ji Y, Xu X, Liu X, Wang Y, Zhou L, Miao Z, Mi QS. Multiple single nucleotide polymorphisms in the human urate transporter 1 (hURAT1) gene are associated with hyperuricaemia in Han Chinese. J Med Genet. 2010 Mar;47(3):204-10. doi: 10.1136/jmg.2009.068619. Epub 2009 Oct 14.
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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.
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 Anthocyanidins capsule and Allopurinol in people with Cardiovascular Disease, run by Guangzhou General Hospital of Guangzhou Military Command 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 2 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: status not confirmed, as of the sponsor's last update on 13 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Dai (020-36653321, daihui66@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of serum uric acid levels in all patients (time frame: up to 1 months). 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 NCT02797028, which also lists 6 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 13 Jun 2016.