Hyperuricemia and Left Ventricular Diastolic Function

NCT03495999 — Terminated, 67 participants, National Defense Medical Center, Taiwan

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

Registry	NCT03495999
Status	Terminated - The study interest was reached
Study type	Observational
Enrollment	67 (Actual)
Sponsor	National Defense Medical Center, Taiwan (Other)
Conditions	Hyperuricemia, Metabolic Syndrome, Left Ventricular Diastolic Dysfunction
Interventions	hyperuricemia (Diagnostic test)
Dates	start 2017-08-01, primary completion 2017-12-15, completion 2018-04-03, first posted 2018-04-12, last updated 2018-04-12
Locations	1 site in Taiwan

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Normouricemia		Diagnostic Test: hyperuricemia	Serum uric of 7mg/dl or less in men or 6mg/dl or less in women
Hyperuricemia		Diagnostic Test: hyperuricemia	Serum uric of 7mg/dl or more in men or 6mg/dl or more in women

hyperuricemia (Diagnostic test): serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women

+Outcome measures

Primary outcomes

Left ventricle diastolic dysfunction with elevated left atrial pressure [1 day]: 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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 20 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Tri-service General Hospital, songshan branch	Taipei, Songshan Dist.	Taiwan

+Investigators

Cheng-Wei Liu, M.D., Principal investigator, Tri-service General hospital, Songshan branch, National defense medical center

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