Study Stopped
The study interest was reached
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
1 other identifier
observational
67
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2017
CompletedFirst Submitted
Initial submission to the registry
April 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedApril 12, 2018
April 1, 2018
5 months
April 3, 2018
April 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
high-sensitivity C-reactive protein
1 week
high-sensitivity interleukin-6
1 month
tumor necrotizing factor alpha
1 month
Study Arms (2)
Normouricemia
Serum uric of 7mg/dl or less in men or 6mg/dl or less in women
Hyperuricemia
Serum uric of 7mg/dl or more in men or 6mg/dl or more in women
Interventions
serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women
Eligibility Criteria
Apparently healthy individuals with metabolic syndrome
You may qualify if:
- Age between 20 to 75 years
- Metabolic syndrome
You may not qualify if:
- Left ventricular ejection fraction \<40%
- Severe valvular heart disease
- Significant structure heart diseases such as hypertrophic, dilated, infiltrative or restrictive cardiomyopathy, or congenital heart disease
- Persistent or chronic atrial fibrillation
- Status post cardiac surgery, including coronary artery bypass surgery of valve intervention
- Status post intra-cardiac device implantation
- Chronic obstructive pulmonary disease
- Severe anemia
- An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-service General Hospital, songshan branch
Taipei, Songshan Dist., 105, Taiwan
Biospecimen
Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheng-Wei Liu, M.D.
Tri-service General hospital, Songshan branch, National defense medical center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 12, 2018
Study Start
August 1, 2017
Primary Completion
December 15, 2017
Study Completion
April 3, 2018
Last Updated
April 12, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share