Urate Lowering Therapies and Left Ventricular Diastolic Dysfunction

NCT03534037 | Unknown Phase 4

• 1 other identifier: 1-107-05-112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperuricemia; Metabolic Syndrome; Left Ventricular Diastolic Dysfunction

Keywords

Serum uric acid; Metabolic syndrome; Left ventricular diastolic dysfunction; Febuxostat; Benzbromarone

Outcome Measures

Primary Outcomes (3)

• Change of average E/e'

  the mean change of average E/e' in each group

  At day1 and at week 12

• Difference of average E/e'

  the mean difference of average E/e' between among three groups

  At day1 and at week 12

• Automate office blood pressure (AOBP)

  the mean difference of AOBP among three groups

  At day1 and at week 12

Secondary Outcomes (18)

• Change of xanthine oxidase activity

  At day1 and at week 12

• Difference of xanthine oxidase activity

  At day1 and at week 12

• Change of left ventricular mass index

  At day1 and at week 12

• Difference of left ventricular mass index

  At day1 and at week 12

• Change of tumor necrosis factor alpha

  At day1 and at week 12

Study Arms (3)

Febuxostat 40mg

EXPERIMENTAL

Febuxostat 40mg orally per day

Drug: Febuxostat 40 mg

Benzbromarone 50mg

ACTIVE COMPARATOR

Benzbromarone 50mg orally per day

Drug: Benzbromarone 50mg

Control

OTHER

Dietary control only

Other: Control

Interventions

Febuxostat 40 mg DRUG

Febuxostat 40 mg orally per day plus dietary control only

Also known as: Feburic

Febuxostat 40mg

Benzbromarone 50mg DRUG

Benzbromarone 50mg orally per day plus dietary control only

Also known as: Nogout

Benzbromarone 50mg

Control OTHER

Dietary control only

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

Tri-service General Hospital, songshan branch

Taipei, Songshan Dist., 105, Taiwan

RECRUITING

MeSH Terms

Conditions

Hyperuricemia; Metabolic Syndrome; Ventricular Dysfunction, Left

Interventions

Febuxostat; Benzbromarone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cheng-Wei Liu, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Wei Liu, M.D.

CONTACT

886-2-27642151; issac700319@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: February 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)