Clinical trial NCT03495999: Hyperuricemia and Left Ventricular Diastolic Function
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyperuricemia
Metabolic Syndrome
Left Ventricular Diastolic Dysfunction
Keywords: Hyperuricemia
Metabolic syndrome
Left ventricular diastolic dysfunction
Inflammation
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Apparently healthy individuals with metabolic syndrome

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricle diastolic dysfunction with elevated left atrial pressure
timeFrame: 1 day
Secondary outcomes:
measure: high-sensitivity C-reactive protein
timeFrame: 1 week
measure: high-sensitivity interleukin-6
timeFrame: 1 month
measure: tumor necrotizing factor alpha
timeFrame: 1 month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service General Hospital, songshan branch
state: Songshan Dist.
Study officials:
affiliation: Tri-service General hospital, Songshan branch, National defense medical center
name: Cheng-Wei Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: