Hyperuricemia and Left Ventricular Diastolic Function

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03495999
• Other study ID #: 2-106-05-078
• Status: Terminated
• First received: April 3, 2018
• Last updated: April 11, 2018
• Start date: August 1, 2017
• Est. completion date: April 3, 2018

Study information

• Verified date: April 2018
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: April 3, 2018
• Est. primary completion date: December 15, 2017
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperuricemia
• Left Ventricular Diastolic Dysfunction
• Metabolic Syndrome
• Metabolic Syndrome X
• Ventricular Dysfunction, Left

Intervention

Diagnostic Test:
• hyperuricemia
serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women

Locations

Country	Name	City	State
Taiwan	Tri-service General Hospital, songshan branch	Taipei	Songshan Dist.

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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