Urate Lowering Therapies and Left Ventricular Diastolic Dysfunction

NCT ID: NCT03534037

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-12-31

Brief 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. 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.

Conditions

Hyperuricemia; Metabolic Syndrome; Left Ventricular Diastolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Febuxostat 40mg

Febuxostat 40mg orally per day

Group Type: EXPERIMENTAL

Febuxostat 40 mg

Intervention Type: DRUG

Febuxostat 40 mg orally per day plus dietary control only

Benzbromarone 50mg

Benzbromarone 50mg orally per day

Group Type: ACTIVE_COMPARATOR

Benzbromarone 50mg

Intervention Type: DRUG

Benzbromarone 50mg orally per day plus dietary control only

Control

Dietary control only

Group Type: OTHER

Control

Intervention Type: OTHER

Dietary control only

Interventions

Febuxostat 40 mg

Febuxostat 40 mg orally per day plus dietary control only

Intervention Type: DRUG

Benzbromarone 50mg

Benzbromarone 50mg orally per day plus dietary control only

Intervention Type: DRUG

Control

Dietary control only

Intervention Type: OTHER

Other Intervention Names

Feburic; Nogout

Eligibility Criteria

Inclusion Criteria

1. Aged between 40-75 years

2. Metabolic syndrome

3. 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

4. Not take any of urate-lowering therapies (benzbromarone, allopurinol, or febuxostat)

Exclusion Criteria

1. pregnancy

2. hypersensitivity to febuxostat or benzbromarone

3. acute gout

4. a history of urinary tract stone

5. chronic kidney disease stage IV or V

6. valvular heart disease with moderate or severe regurgitation

7. left ventricular ejection fraction of 40% or less

8. hypertrophic cardiomyopathy or dilated cardiomyopathy or infiltrative cardiomyopathy or constrictive cardiomyopathy

9. a history of congenital heart disease

10. a history of pulmonary hypertension

11. chronic atrial fibrillation or significant arrhythmia

12. a history of intracardiac device implantation

13. uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood pressure > 100 mm Hg)

14. alanine Aminotransferase > 3 times upper limit)

15. acute infection

16. suspected or diagnosed with malignancy

17. a history of autoimmune disease

18. limited to or dependent on daily activities

19. life expectancy less than a year

20. Acute coronary syndrome or received a percutaneous coronary intervention or received a coronary artery graft bypass surgery or stroke within 3 months

21. Diabetes with insulin treatment or glucagon-like peptide 1 receptor agonist treatment

22. Anemia (hemoglobin < 11 mg/dl in mem or <10mg/dl in women)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Cheng-Wei Liu

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng-Wei Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

1.Tri-service General hospital, Songshan branch, Taipei, Taiwan

Locations

Tri-service General Hospital, songshan branch

Taipei, Songshan Dist., Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Cheng-Wei Liu, M.D.

Role: CONTACT

issac700319@gmail.com

886-2-27642151 ext. 671401

Facility Contacts

Liu, MD

Role: primary

issac700319@gmail.com

+886-910682383

Other Identifiers

1-107-05-112

Identifier Type: -

Identifier Source: org_study_id