Hyperuricemia and Left Ventricular Diastolic Function

Associations and Plausibility Among Left Ventricle Diastolic Function, Serum Uric Acid and Inflammatory Biomarkers in Individuals With Cardiometabolic Risks - A Prospective Observational Study

Metabolic syndrome and hyperuricemia were both associated with inflammation, leading to diversities of cardiovascular disease such as left ventricular diastolic dysfunction, but the relationship among these entities remained unclear. The aim of the present study focuses on the association among hyperuricemia, diastolic dysfunction and inflammatory biomarkers in apparently healthy individuals with metabolic syndrome

Study Overview

• Status: Terminated
• Conditions: Metabolic Syndrome; Hyperuricemia; Left Ventricular Diastolic Dysfunction
• Intervention / Treatment: Diagnostic test: hyperuricemia

Detailed Description

Apparently healthy individuals with metabolic syndrome were prospectively and consecutively enrolled since August 2017. Blood samples were obtained after participants are fasting for at least 12 hours, including serum uric acid, high-sensitivity C-reactive protein, high-sensitivity interleukin-6, tumor necrotizing factor alpha, fasting glucose, glycosylated hemoglobin, insulin, lipid profile, creatinine, alanine aminotransferase, sodium, potassium, and calcium. All echocardiographic parameters were measured in accordance with the American Society of Echocardiography guidelines.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Taiwan
  • Songshan Dist.
    • Taipei, Songshan Dist., Taiwan, 105
      • Tri-Service General Hospital, Songshan Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Apparently healthy individuals with metabolic syndrome

Description

Inclusion Criteria:

1. Age between 20 to 75 years
2. Metabolic syndrome

Exclusion Criteria:

1. Left ventricular ejection fraction <40%
2. Severe valvular heart disease
3. Significant structure heart diseases such as hypertrophic, dilated, infiltrative or restrictive cardiomyopathy, or congenital heart disease
4. Persistent or chronic atrial fibrillation
5. Status post cardiac surgery, including coronary artery bypass surgery of valve intervention
6. Status post intra-cardiac device implantation
7. Chronic obstructive pulmonary disease
8. Severe anemia
9. An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normouricemia; Serum uric of 7mg/dl or less in men or 6mg/dl or less in women	Diagnostic test: hyperuricemia; serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women
Hyperuricemia; Serum uric of 7mg/dl or more in men or 6mg/dl or more in women	Diagnostic test: hyperuricemia; serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricle diastolic dysfunction with elevated left atrial pressure	The contemporary definition of left ventricular diastolic dysfunction with elevated left atrial pressure is mainly >50% positive of the following criteria: (1) average E/e' ≥14 (2) left atrial volume index >34 ml/m2 (3) tricuspid regurgitation velocity >2.8 m/s	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high-sensitivity C-reactive protein	determined by Latex enhanced immunoturbidimetric，ADVIA 1800，ADVIA Chemistry XPT，Dimension RXL，SIEMENS，AU 640，Beckman Coulter	1 week
high-sensitivity interleukin-6	determined by elisa enzyme-linked immunosorbent assay, R & D system	1 month
tumor necrotizing factor alpha	determined by elisa enzyme-linked immunosorbent assay	1 month

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Investigators: Principal Investigator: Cheng-Wei Liu, M.D., Tri-service General hospital, Songshan branch, National defense medical center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): April 3, 2018

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Metabolic syndrome; Hyperuricemia; Left ventricular diastolic dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Ventricular Dysfunction; Metabolic Syndrome; Hyperuricemia; Ventricular Dysfunction, Left
• Other Study ID Numbers: 2-106-05-078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No