ClinicalTrials.gg
TerminatedNCT03495999Updated Apr 12, 2018

Hyperuricemia and Left Ventricular Diastolic Function

An observational study in Hyperuricemia, Metabolic Syndrome and Left Ventricular Diastolic Dysfunction, sponsored by National Defense Medical Center, Taiwan. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-12.

Sponsored by National Defense Medical Center, Taiwan · Observational

Why this study was terminated
The study interest was reached
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
67
Ages
20 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hyperuricemia
  • Metabolic Syndrome
  • Left Ventricular Diastolic Dysfunction

Keywords

  • Hyperuricemia
  • Metabolic syndrome
  • Left ventricular diastolic dysfunction
  • Inflammation
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In context

Hyperuricemia

240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.

This study's enrollment of 67 is below the median of 183 across 40 observational studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

National Defense Medical Center, Taiwan is the lead sponsor of 64 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Apparently healthy individuals with metabolic syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. \<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. Severe anemia
  8. An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
67 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Normouricemia

    Serum uric of 7mg/dl or less in men or 6mg/dl or less in women

    Diagnostic Test: hyperuricemia

  • Hyperuricemia

    Serum uric of 7mg/dl or more in men or 6mg/dl or more in women

    Diagnostic Test: hyperuricemia

Interventions

  • Diagnostic testhyperuricemia

    serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women

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What researchers measure

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

    Time frame: 1 day

Secondary outcomes

  1. high-sensitivity C-reactive protein

    determined by Latex enhanced immunoturbidimetric,ADVIA 1800,ADVIA Chemistry XPT,Dimension RXL,SIEMENS,AU 640,Beckman Coulter

    Time frame: 1 week

  2. high-sensitivity interleukin-6

    determined by elisa enzyme-linked immunosorbent assay, R \& D system

    Time frame: 1 month

  3. tumor necrotizing factor alpha

    determined by elisa enzyme-linked immunosorbent assay

    Time frame: 1 month

07

Study locations

1 site
  • Tri-service General Hospital, songshan branch
    Taipei, Songshan Dist. 105, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Dec 2017, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2018
First posted
Apr 12, 2018
StartActual
Aug 1, 2017
Primary completionActual
Dec 15, 2017
CompletionActual
Apr 3, 2018
Last update
Apr 12, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03495999
Lead sponsor
National Defense Medical Center, Taiwan
Responsible party
Cheng-Wei Liu (Cardiologist, National Defense Medical Center, Taiwan) — Principal investigator
First posted
Apr 12, 2018
Start date
Aug 1, 2017
Primary completion
Dec 15, 2017
Completion
Apr 3, 2018
Last update
Apr 12, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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