Urate Lowering Therapies and Left Ventricular Diastolic Dysfunction

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Defense Medical Center, Taiwan
• Treatments: Benzbromarone; Febuxostat

Criteria

Inclusion Criteria (all of the four 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)