HypertensionNCT04554069
Effect of Different Antihypertensive Treatment on Serum Uric Acid in Newly Diagnosed Hypertensive Patients
An observational study of Hypertension, run by Assiut University.
Trial summary
Assessment of the influence of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension patients. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to Feb 2022
- 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 30 years and older
- All sexes
- Adult, Older adult
Study population: Male and Female participants aged 30 years old and above will be invited to participate in this study.
Who may be able to join
- All newly diagnosed hypertensive patients aged 30 years old and above will be invited to participate in this study
Who cannot join
- Patients below 30 years old.
- Patients with kidney disease.
- Patients who are taking medications known to increase SUA as (Thiazide and Loop diuretics, Salicylates, Cyclosporin use) or decrease the level of uric acid in the urine as (Allopurinol, Febuoxstate).
Trial locations and contacts
No sites are listed yet.
About this study
Assessment of the influence of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension patients.
Read the detailed description
Hypertension is the most common condition seen in primary care and leads to myocardial infarction, stroke, renal failure, and death if not detected early and treated appropriately.
Thiazide-type diuretics, angiotensin-converting enzyme (ACE) inhibitors and some of angiotensin-II receptor blockers (ARB) were reported to reduce renal excretion of urate and increased serum uric acid levels, Beta-blockers also elevate serum uric acid levels.
Hyperuricemia is a risk factor for cardiovascular diseases. Hyperuricemia was found to correlate with hypertension excluding the influence of other factors such as age and renal function. Furthermore, many studies found that hyperuricemia was independently associated with cardiovascular events in patients treated with antihypertensive drugs.
It is important to control serum uric acid levels in hypertensive patients treated with antihypertensive drugs in order to reduce the risk of gout and cardiovascular events. There is a gap in knowledge in studies showing the effect of antihypertensive drugs on serum uric acid in newly diagnosed hypertensive patients.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension.
we will measure the change of the level of serum uric acid after 6 months from the treatment of antihypertensive durgs
Measured: 6 months from baseline
Secondary outcomes (1)
obesity
it will be measured by BMI (kg/m2)
Measured: 6 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Jun 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mahran, Assiut University
- Investigators
- Dalia Mahran, Professor, Principal investigator, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554069
- Sponsor's protocol ID
- Uric acid in Hypertension
- Status last verified
- Jan 2021
- First submitted
- 5 Sep 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verdecchia P, Schillaci G, Reboldi G, Santeusanio F, Porcellati C, Brunetti P. Relation between serum uric acid and risk of cardiovascular disease in essential hypertension. The PIUMA study. Hypertension. 2000 Dec;36(6):1072-8. doi: 10.1161/01.hyp.36.6.1072.
PubMed 11116127Shankar A, Klein R, Klein BE, Nieto FJ. The association between serum uric acid level and long-term incidence of hypertension: Population-based cohort study. J Hum Hypertens. 2006 Dec;20(12):937-45. doi: 10.1038/sj.jhh.1002095. Epub 2006 Oct 5.
PubMed 17024135
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Antihypertensive Treatment on Serum Uric Acid in Newly Diagnosed Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04554069
- Acronym / sponsor ID
- Uric acid in Hypertension
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 18 Sep 2020 (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.
Assessment of the influence of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension patients.
Detailed description
Hypertension is the most common condition seen in primary care and leads to myocardial infarction, stroke, renal failure, and death if not detected early and treated appropriately.
Thiazide-type diuretics, angiotensin-converting enzyme (ACE) inhibitors and some of angiotensin-II receptor blockers (ARB) were reported to reduce renal excretion of urate and increased serum uric acid levels, Beta-blockers also elevate serum uric acid levels.
Hyperuricemia is a risk factor for cardiovascular diseases. Hyperuricemia was found to correlate with hypertension excluding the influence of other factors such as age and renal function. Furthermore, many studies found that hyperuricemia was independently associated with cardiovascular events in patients treated with antihypertensive drugs.
It is important to control serum uric acid levels in hypertensive patients treated with antihypertensive drugs in order to reduce the risk of gout and cardiovascular events. There is a gap in knowledge in studies showing the effect of antihypertensive drugs on serum uric acid in newly diagnosed hypertensive patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and Female participants aged 30 years old and above will be invited to participate in this study.
Key inclusion criteria (1 listed)
- All newly diagnosed hypertensive patients aged 30 years old and above will be invited to participate in this study
Key exclusion criteria (3 listed)
- Patients below 30 years old.
- Patients with kidney disease.
- Patients who are taking medications known to increase SUA as (Thiazide and Loop diuretics, Salicylates, Cyclosporin use) or decrease the level of uric acid in the urine as (Allopurinol, Febuoxstate).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The effect of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension.
Time frame: 6 months from baseline
we will measure the change of the level of serum uric acid after 6 months from the treatment of antihypertensive durgs
1 secondary outcome
obesity
Time frame: 6 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 11116127Verdecchia P, Schillaci G, Reboldi G, Santeusanio F, Porcellati C, Brunetti P. Relation between serum uric acid and risk of cardiovascular disease in essential hypertension. The PIUMA study. Hypertension. 2000 Dec;36(6):1072-8. doi: 10.1161/01.hyp.36.6.1072.
- Background: PubMed 17024135Shankar A, Klein R, Klein BE, Nieto FJ. The association between serum uric acid level and long-term incidence of hypertension: Population-based cohort study. J Hum Hypertens. 2006 Dec;20(12):937-45. doi: 10.1038/sj.jhh.1002095. Epub 2006 Oct 5.
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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.
Dalia Mahran, Professor principal investigator
faculty of medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mentallah Abdelrahman, MBBCH (+201092772639, menahallah.osama@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of different antihypertensive drugs on serum uric acid in newly diagnosed hypertension. (time frame: 6 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554069, which also lists 2 linked publications.
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 22 Jan 2021.