HyperuricemiaPhase 4NCT03534037
Urate Lowering Therapies and Left Ventricular Diastolic Dysfunction
A Phase 4 study testing Febuxostat 40 mg and Benzbromarone 50mg in people with Hyperuricemia and Metabolic Syndrome, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
Hyperuricemia is an additional risk factor for cardiovascular disease, associating with left ventricular diastolic dysfunction in individuals with metabolic syndrome. The effect of urate-lowering therapies on left ventricular diastolic dysfunction remains unclear. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hyperuricemia, Metabolic Syndrome, Left Ventricular Diastolic Dysfunction
- What is being tested?
- Febuxostat 40 mg and Benzbromarone 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to Dec 2021
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40-75 years
- Metabolic syndrome
- Hyperuricemia, defined as a serum uric acid level of 7 mg/dl or more in men or 6 mg/dl or more in females, with a history of hyperuricemia within a year; or a serum uric acid level of 8 mg/dl or more in men or 7 mg/dl or more in females and it is hardly expected to be modified by dietary control; or persistent hyperuricemia after dietary control for 3 months
- Not take any of urate-lowering therapies (benzbromarone, allopurinol, or febuxostat)
Who cannot join
- pregnancy
- hypersensitivity to febuxostat or benzbromarone
- acute gout
- a history of urinary tract stone
- chronic kidney disease stage IV or V
- valvular heart disease with moderate or severe regurgitation
Show all 22Show fewer
- left ventricular ejection fraction of 40% or less
- hypertrophic cardiomyopathy or dilated cardiomyopathy or infiltrative cardiomyopathy or constrictive cardiomyopathy
- a history of congenital heart disease
- a history of pulmonary hypertension
- chronic atrial fibrillation or significant arrhythmia
- a history of intracardiac device implantation
- uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood pressure > 100 mm Hg)
- alanine Aminotransferase > 3 times upper limit)
- acute infection
- suspected or diagnosed with malignancy
- a history of autoimmune disease
- limited to or dependent on daily activities
- life expectancy less than a year
- Acute coronary syndrome or received a percutaneous coronary intervention or received a coronary artery graft bypass surgery or stroke within 3 months
- Diabetes with insulin treatment or glucagon-like peptide 1 receptor agonist treatment
- Anemia (hemoglobin < 11 mg/dl in mem or <10mg/dl in women)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-service General Hospital, songshan branch
Taipei, Songshan Dist., 105
Liu, MD, +886-910682383, issac700319@gmail.com
Cheng-Wei Liu, MD
About this study
Official title: The Cardiovascular Effects of Febuxostat and Benzbromarone on Left Ventricle Diastolic Dysfunction in Individuals With Metabolic Syndrome and Hyperuricemia - an Open-label Non-blinded Randomized-controlled Clinical Trial
Hyperuricemia is an additional risk factor for cardiovascular disease, associating with left ventricular diastolic dysfunction in individuals with metabolic syndrome. The effect of urate-lowering therapies on left ventricular diastolic dysfunction remains unclear. The study is conducted to investigate whether febuxostat or benzbromarone might improve left ventricular diastolic dysfunction in individuals with metabolic syndrome and hyperuricemia
Read the detailed description
Between 1, July 2018 and 31, Dec 2018, consecutive individuals with metabolic syndrome hyperuricemia are candidates of the present study. After the eligible candidates sign the informed consent, they will receive blood tests with a fasting time of 8 hours at least. The investigators will randomize the study participants by pre-specified random codes with a 1:1:1 ratio to the three groups. The study medication, febuxostat or benzbromarone, will be administered orally on the next day after transthoracic echocardiography is performed. The control group will only receive dietary control. All participant will receive transthoracic echocardiography and blood tests at baseline and at 3 months. The visit will be scheduled at baseline and at the 3rd month. The blood tests include high-sensitivity C-reactive protein, high-sensitivity interleukin-1 beta, high-sensitivity interleukin-6, tumor necrosis factor alpha, Dickkopf-related protein 3, galectin-3, ST2, fibroblast growth factor 23, xanthine oxidase activity, and thioredoxin.
- Being tested
- Febuxostat 40 mg, Benzbromarone 50mg, Control
- Keywords
- Serum uric acid, Metabolic syndrome, Left ventricular diastolic dysfunction, Febuxostat, Benzbromarone
- Medical subject headings
- Hyperuricemia, Metabolic Syndrome, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Febuxostat 40 mgDrug
Also called Feburic
Febuxostat 40 mg orally per day plus dietary control only
Benzbromarone 50mgDrug
Also called Nogout
Benzbromarone 50mg orally per day plus dietary control only
ControlOther
Dietary control only
| Study group | Role | What they receive |
|---|---|---|
| Febuxostat 40mg | Experimental | Febuxostat 40mg orally per day Receives: Drug: Febuxostat 40 mg |
| Benzbromarone 50mg | Active comparator | Benzbromarone 50mg orally per day Receives: Drug: Benzbromarone 50mg |
| Control | Other | Dietary control only Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of average E/e'
the mean change of average E/e' in each group
Measured: At day1 and at week 12
Difference of average E/e'
the mean difference of average E/e' between among three groups
Measured: At day1 and at week 12
Automate office blood pressure (AOBP)
the mean difference of AOBP among three groups
Measured: At day1 and at week 12
Secondary outcomes (18)
Change of xanthine oxidase activity
the mean change of xanthine oxidase activity in each group
Measured: At day1 and at week 12
Difference of xanthine oxidase activity
the mean difference of xanthine oxidase activity among three groups
Measured: At day1 and at week 12
Change of left ventricular mass index
the mean change of left ventricular mass index in each group
Measured: At day1 and at week 12
Difference of left ventricular mass index
the mean difference of left ventricular mass index among three groups
Measured: At day1 and at week 12
Change of tumor necrosis factor alpha
the mean change of tumor necrosis factor alpha in each group
Measured: At day1 and at week 12
Difference of tumor necrosis factor alpha
the mean difference of tumor necrosis factor alpha among three groups
Measured: At day1 and at week 12
Change of high-sensitivity interleukin-6
the mean change of high-sensitivity interleukin-6 in each group
Measured: At day1 and at week 12
Difference of high-sensitivity interleukin-6
the mean difference of high-sensitivity interleukin-6 among three groups
Measured: At day1 and at week 12
Change of thioredoxin
the mean change of Thioredoxin in each group
Measured: At day1 and at week 12
Difference of Thioredoxin
the mean difference of Thioredoxin among three group
Measured: At day1 and at week 12
Change of fibroblast growth factor 23
the mean Change of fibroblast growth factor 23 in each group
Measured: At day1 and at week 12
Difference of fibroblast growth factor 23
the mean difference of fibroblast growth factor 23 among three groups
Measured: At day1 and at week 12
Change of Dickkopf-related protein 3
the mean change of Dickkopf-related protein 3 in each group
Measured: At day1 and at week 12
Difference of Dickkopf-related protein 3
the mean difference of Dickkopf-related protein 3 among three groups
Measured: At day1 and at week 12
Change of galectin-3
the mean change of galectin-3 in each group
Measured: At day1 and at week 12
Difference of galectin-3
the mean difference of galectin-3 among three groups
Measured: At day1 and at week 12
Change of ST2
the mean change of ST2 in each group
Measured: At day1 and at week 12
Difference of ST2
the mean difference of ST2 among three groups
Measured: At day1 and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Feb 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Wei Liu, National Defense Medical Center, Taiwan
- Investigators
- Cheng-Wei Liu, M.D., Principal investigator, 1.Tri-service General hospital, Songshan branch, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534037
- Sponsor's protocol ID
- 1-107-05-112
- Status last verified
- Apr 2020
- First submitted
- 11 May 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiovascular Effects of Febuxostat and Benzbromarone on Left Ventricle Diastolic Dysfunction in Individuals With Metabolic Syndrome and Hyperuricemia - an Open-label Non-blinded Randomized-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03534037
- Acronym / sponsor ID
- 1-107-05-112
- Keywords
- Serum uric acid, Metabolic syndrome, Left ventricular diastolic dysfunction, Febuxostat, Benzbromarone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 May 2018 (actual)
- 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.
Hyperuricemia is an additional risk factor for cardiovascular disease, associating with left ventricular diastolic dysfunction in individuals with metabolic syndrome. The effect of urate-lowering therapies on left ventricular diastolic dysfunction remains unclear. The study is conducted to investigate whether febuxostat or benzbromarone might improve left ventricular diastolic dysfunction in individuals with metabolic syndrome and hyperuricemia
Detailed description
Between 1, July 2018 and 31, Dec 2018, consecutive individuals with metabolic syndrome hyperuricemia are candidates of the present study. After the eligible candidates sign the informed consent, they will receive blood tests with a fasting time of 8 hours at least. The investigators will randomize the study participants by pre-specified random codes with a 1:1:1 ratio to the three groups. The study medication, febuxostat or benzbromarone, will be administered orally on the next day after transthoracic echocardiography is performed. The control group will only receive dietary control. All participant will receive transthoracic echocardiography and blood tests at baseline and at 3 months. The visit will be scheduled at baseline and at the 3rd month. The blood tests include high-sensitivity C-reactive protein, high-sensitivity interleukin-1 beta, high-sensitivity interleukin-6, tumor necrosis factor alpha, Dickkopf-related protein 3, galectin-3, ST2, fibroblast growth factor 23, xanthine oxidase activity, and thioredoxin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Febuxostat 40mg | Experimental | Drug: Febuxostat 40 mgFebuxostat 40mg orally per day |
| Benzbromarone 50mg | Active comparator | Drug: Benzbromarone 50mgBenzbromarone 50mg orally per day |
| Control | Other | Other: ControlDietary control only |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 40-75 years
- Metabolic syndrome
- Hyperuricemia, defined as a serum uric acid level of 7 mg/dl or more in men or 6 mg/dl or more in females, with a history of hyperuricemia within a year; or a serum uric acid level of 8 mg/dl or more in men or 7 mg/dl or more in females and it is hardly expected to be modified by dietary control; or persistent hyperuricemia after dietary control for 3 months
- Not take any of urate-lowering therapies (benzbromarone, allopurinol, or febuxostat)
Key exclusion criteria (22 listed)
- pregnancy
- hypersensitivity to febuxostat or benzbromarone
- acute gout
- a history of urinary tract stone
- chronic kidney disease stage IV or V
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 |
|---|---|---|
| Febuxostat 40 mgAlso: FeburicFebuxostat 40 mg orally per day plus dietary control only | Drug | Febuxostat 40mg |
| Benzbromarone 50mgAlso: NogoutBenzbromarone 50mg orally per day plus dietary control only | Drug | Benzbromarone 50mg |
| ControlDietary control only | Other | Control |
Primary outcome
Change of average E/e'
Time frame: At day1 and at week 12
the mean change of average E/e' in each group
Difference of average E/e'
Time frame: At day1 and at week 12
the mean difference of average E/e' between among three groups
Automate office blood pressure (AOBP)
Time frame: At day1 and at week 12
the mean difference of AOBP among three groups
18 secondary outcomes
Change of xanthine oxidase activity
Time frame: At day1 and at week 12
Difference of xanthine oxidase activity
Time frame: At day1 and at week 12
Change of left ventricular mass index
Time frame: At day1 and at week 12
Difference of left ventricular mass index
Time frame: At day1 and at week 12
Change of tumor necrosis factor alpha
Time frame: At day1 and at week 12
Difference of tumor necrosis factor alpha
Time frame: At day1 and at week 12
Change of high-sensitivity interleukin-6
Time frame: At day1 and at week 12
Difference of high-sensitivity interleukin-6
Time frame: At day1 and at week 12
Change of thioredoxin
Time frame: At day1 and at week 12
Difference of Thioredoxin
Time frame: At day1 and at week 12
Change of fibroblast growth factor 23
Time frame: At day1 and at week 12
Difference of fibroblast growth factor 23
Time frame: At day1 and at week 12
Change of Dickkopf-related protein 3
Time frame: At day1 and at week 12
Difference of Dickkopf-related protein 3
Time frame: At day1 and at week 12
Change of galectin-3
Time frame: At day1 and at week 12
Difference of galectin-3
Time frame: At day1 and at week 12
Change of ST2
Time frame: At day1 and at week 12
Difference of ST2
Time frame: At day1 and at week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Hyperuricemia
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Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
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Active, not recruiting
Acute Effects of a Urate-lowering Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects
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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.
Cheng-Wei Liu, M.D. principal investigator
1.Tri-service General hospital, Songshan branch, Taipei, Taiwan
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 Febuxostat 40 mg and Benzbromarone 50mg in people with Hyperuricemia and Metabolic Syndrome, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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 4 inclusion and 22 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 28 Apr 2020. 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 Taiwan. 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. 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 Cheng-Wei Liu, M.D. (886-2-27642151 ext. 671401, issac700319@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of average E/e' (time frame: At day1 and at week 12). The study lists 3 primary outcomes in all. 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 28 Apr 2020; AzTrials last refreshed its copy on 29 Oct 2026.