HyperuricemiaNCT03495999
Hyperuricemia and Left Ventricular Diastolic Function
An observational study of Hyperuricemia and Metabolic Syndrome, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hyperuricemia, Metabolic Syndrome, Left Ventricular Diastolic Dysfunction
- What is being tested?
- hyperuricemia
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 3 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: Apparently healthy individuals with metabolic syndrome
Who may be able to join
- Age between 20 to 75 years
- Metabolic syndrome
Who cannot join
- 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
Show all 9Show fewer
- Chronic obstructive pulmonary disease
- Severe anemia
- An obvious systemic disease that interferes left ventricular diastolic dysfunction such as acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Tri-service General Hospital, songshan branch
Taipei, Songshan Dist., 105
About this study
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
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.
- Being tested
- hyperuricemia
- Keywords
- Hyperuricemia, Metabolic syndrome, Left ventricular diastolic dysfunction, Inflammation
- Medical subject headings
- Hyperuricemia, Metabolic Syndrome, Ventricular Dysfunction, Left, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperuricemiaDiagnostic test
serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women
| Study group | Role | What they receive |
|---|---|---|
| Normouricemia | Serum uric of 7mg/dl or less in men or 6mg/dl or less in women Receives: Diagnostic Test: hyperuricemia | |
| Hyperuricemia | Serum uric of 7mg/dl or more in men or 6mg/dl or more in women Receives: Diagnostic Test: hyperuricemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
high-sensitivity C-reactive protein
determined by Latex enhanced immunoturbidimetric，ADVIA 1800，ADVIA Chemistry XPT，Dimension RXL，SIEMENS，AU 640，Beckman Coulter
Measured: 1 week
high-sensitivity interleukin-6
determined by elisa enzyme-linked immunosorbent assay, R \& D system
Measured: 1 month
tumor necrotizing factor alpha
determined by elisa enzyme-linked immunosorbent assay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Aug 2017
- Primary completion15 Dec 2017
- Study completion3 Apr 2018
Why it stopped: The study interest was reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Wei Liu, National Defense Medical Center, Taiwan
- Investigators
- Cheng-Wei Liu, M.D., Principal investigator, Tri-service General hospital, Songshan branch, National defense medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495999
- Sponsor's protocol ID
- 2-106-05-078
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03495999
- Acronym / sponsor ID
- 2-106-05-078
- Keywords
- Hyperuricemia, Metabolic syndrome, Left ventricular diastolic dysfunction, Inflammation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study interest was reached
- Enrolment
- 67 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normouricemia | – | Diagnostic Test: hyperuricemiaSerum uric of 7mg/dl or less in men or 6mg/dl or less in women |
| Hyperuricemia | – | Diagnostic Test: hyperuricemiaSerum uric of 7mg/dl or more in men or 6mg/dl or more in women |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Apparently healthy individuals with metabolic syndrome
Key inclusion criteria (2 listed)
- Age between 20 to 75 years
- Metabolic syndrome
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperuricemiaserum uric acid of 7mg/dl or more in men or 6mg/dl or more in women | Diagnostic test | Hyperuricemia, Normouricemia |
Primary outcome
Left ventricle diastolic dysfunction with elevated left atrial pressure
Time frame: 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
3 secondary outcomes
high-sensitivity C-reactive protein
Time frame: 1 week
high-sensitivity interleukin-6
Time frame: 1 month
tumor necrotizing factor alpha
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The study interest was reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Wei Liu, M.D. principal investigator
Tri-service General hospital, Songshan branch, National defense medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricemia and Metabolic Syndrome, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study interest was reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricle diastolic dysfunction with elevated left atrial pressure (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.