Salt Hypertension From Excess Dietary SaltNCT03385070
Salt Sensitivity Hypertension and Lens Opacities
An observational study of Salt Hypertension From Excess Dietary Salt and Lens Opacities, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Salt-sensitive hypertension (SSH) accounts for about the half of all Hypertension (HT) cases .In SSH, Na+/K+-ATPase activity is impaired. Impaired Na+/K+-ATPase activity in the lens epithelium results in cortical opacities in the peripheral equator of the lens. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Salt Hypertension From Excess Dietary Salt, Lens Opacities
- What is being tested?
- Lens examination
- How many people
- 429 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2017to 7 Dec 2017
- How long will I take part?
- 6 Months
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The HT and control groups were subdivided into age groups of < 50, 50-59, 60-69, and ≥ 70 years. These age groups comprised 54, 109, 80, and 62 patients in the HT group and 19, 42, 42, and 21 patients in the control group, respectively.
Who may be able to join
- Salt Sensitivity Hypertension patients Non-SSH, salt-resistant HT (SRH) patients Control patients without HT, aged 40-80 years.
Who cannot join
- Cataracts Diabetes Mellitus Smoking Hypo/hypercalcemia Hyperparathyroidism Eye trauma Coronary artery disease Cardiac failure Renal failure
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences.Keçiören Education and Training Hospital
Ankara, 06400
About this study
Official title: Using Lens Opacities to Predict Salt Sensitivity Hypertension
Salt-sensitive hypertension (SSH) accounts for about the half of all Hypertension (HT) cases .In SSH, Na+/K+-ATPase activity is impaired. Impaired Na+/K+-ATPase activity in the lens epithelium results in cortical opacities in the peripheral equator of the lens.
This study analyzed 305 patients with hypertension aged between 40 and 80 years and 124 non-HT controls. A total of 163 patients with HT who were admitted to the emergency service at least once with a minimum increase of 10% in their systolic and diastolic blood pressure after consuming salted food met the eligible criteria for HT and were included in the SSH group. A total of 142 patients who were previously diagnosed with HT but had no previous history were considered non-SSH. Two researchers examined the presence of cortical lens opacities biomicroscopically using the diffuse, direct, Scheimpflug, and retroillumination from fundus methods.
Read the detailed description
The number of patients with hypertension (HT) worldwide is estimated to reach 1.56 billion by 2025.HT accounts for almost 50% of deaths due to stroke and coronary artery disease. Salt-sensitive hypertension (SSH) accounts for about the half of all HT cases. Na+ /K+-ATPase activity is impaired in patients with SSH . Impaired Na+ /K+-ATPase activity in the lens epithelium results in cortical opacities in the peripheral equatorial region of the lens.A definite diagnosis of salt sensitivity is difficult, expensive, and associated with low patient compliance. Salt sensitivity is a risk factor for cardiovascular mortality and morbidity regardless of blood pressure and for other diseases such as asthma, gastric carcinoma, osteoporosis, and renal dysfunction. The present study is the first to investigate the potential of using lens opacity to predict SSH.
The transparency of the whole lens is largely based on epithelial cell permeability and Na+ /K+-ATPase activity. Circulation is activated by Na+ /K+-ATPases, which are present at 20-fold normal concentrations, particularly in the equatorial than in the anterior epithelial cells.
The mechanisms associated with SSH pathogenesis, such as signaling pathways involving Src family kinase (SFK), endothelin, connexin, brain natriuretic peptide (BNP), aldosterone, transient receptor protein V4 (TRPV4) ion channel, with-no-lysine kinase-Ste20-like proline/alanine rich kinase/oxidative stress-responsive kinase 1 (WNK-SPAK/OSR1), and Ras-related C3 botulinum toxin substrate (Rac1) , are important to the physiology of the lens epithelium. Compelling studies suggest that inhibition of these pathways may facilitate opacity.
- Being tested
- Lens examination
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lens examinationDiagnostic test
Also called urine analysis for salt intake, Blood pressure measurements
The presence of cortical lens opacity was biomicroscopically examined by two researchers using the diffuse, direct, Scheimpflug and retroillumination from the fundus methods.
| Study group | Role | What they receive |
|---|---|---|
| Salt-sensitive group | Patients (n:163)with HT who presented at the emergency service at least once with a minimum increase in their systolic and diastolic blood pressure of 10% after consuming salty foods were included in the SSH group.
Biomicroscopic lens examination,urine analysis for salt intake estimation,blood pressure measurements Receives: Diagnostic Test: Lens examination | |
| Salt resistance group | Patients(n:142) who did not exhibit this increase were included in the SRH group
Biomicroscopic lens examination,urine analysis for salt intake estimation,blood pressure measurements Receives: Diagnostic Test: Lens examination | |
| Control group | Sex- and age-matched patients(n:124) without a HT diagnosis were included in the control group.
Biomicroscopic lens examination,urine analysis for salt intake estimation,blood pressure measurements Receives: Diagnostic Test: Lens examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens examination
Biomicroscopic lens examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start15 Mar 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt Hypertension From Excess Dietary SaltStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 429 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keçiören Eğitim Araştırma Hastanesi, Kecioren Education and Training Hospital
- Investigators
- Şahbender Koç, Cardiologist, Principal investigator, Keçiören Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385070
- Sponsor's protocol ID
- 8.3.2017/1325
- Status last verified
- Dec 2017
- First submitted
- 20 Dec 2017
- Last updated
- 29 Dec 2017
- 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 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Lens Opacities to Predict Salt Sensitivity Hypertension
- ClinicalTrials.gov ID
- NCT03385070
- Acronym / sponsor ID
- 8.3.2017/1325
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 28 Dec 2017 (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.
Salt-sensitive hypertension (SSH) accounts for about the half of all Hypertension (HT) cases .In SSH, Na+/K+-ATPase activity is impaired. Impaired Na+/K+-ATPase activity in the lens epithelium results in cortical opacities in the peripheral equator of the lens.
This study analyzed 305 patients with hypertension aged between 40 and 80 years and 124 non-HT controls. A total of 163 patients with HT who were admitted to the emergency service at least once with a minimum increase of 10% in their systolic and diastolic blood pressure after consuming salted food met the eligible criteria for HT and were included in the SSH group. A total of 142 patients who were previously diagnosed with HT but had no previous history were considered non-SSH. Two researchers examined the presence of cortical lens opacities biomicroscopically using the diffuse, direct, Scheimpflug, and retroillumination from fundus methods.
Detailed description
The number of patients with hypertension (HT) worldwide is estimated to reach 1.56 billion by 2025.HT accounts for almost 50% of deaths due to stroke and coronary artery disease. Salt-sensitive hypertension (SSH) accounts for about the half of all HT cases. Na+ /K+-ATPase activity is impaired in patients with SSH . Impaired Na+ /K+-ATPase activity in the lens epithelium results in cortical opacities in the peripheral equatorial region of the lens.A definite diagnosis of salt sensitivity is difficult, expensive, and associated with low patient compliance. Salt sensitivity is a risk factor for cardiovascular mortality and morbidity regardless of blood pressure and for other diseases such as asthma, gastric carcinoma, osteoporosis, and renal dysfunction. The present study is the first to investigate the potential of using lens opacity to predict SSH.
The transparency of the whole lens is largely based on epithelial cell permeability and Na+ /K+-ATPase activity. Circulation is activated by Na+ /K+-ATPases, which are present at 20-fold normal concentrations, particularly in the equatorial than in the anterior epithelial cells.
The mechanisms associated with SSH pathogenesis, such as signaling pathways involving Src family kinase (SFK), endothelin, connexin, brain natriuretic peptide (BNP), aldosterone, transient receptor protein V4 (TRPV4) ion channel, with-no-lysine kinase-Ste20-like proline/alanine rich kinase/oxidative stress-responsive kinase 1 (WNK-SPAK/OSR1), and Ras-related C3 botulinum toxin substrate (Rac1) , are important to the physiology of the lens epithelium. Compelling studies suggest that inhibition of these pathways may facilitate opacity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salt-sensitive group | – | Diagnostic Test: Lens examinationPatients (n:163)with HT who presented at the emergency service at least once with a minimum increase in their systolic and diastolic blood pressure of 10% after consuming salty foods were included in the SSH group. Biomicroscopic lens examination,urine analysis for salt intake estimation,blood pressure measurements |
| Salt resistance group | – | Diagnostic Test: Lens examinationPatients(n:142) who did not exhibit this increase were included in the SRH group Biomicroscopic lens examination,urine analysis for salt intake estimation,blood pressure measurements |
| Control group | – | Diagnostic Test: Lens examinationSex- and age-matched patients(n:124) without a HT diagnosis were included in the control group. Biomicroscopic lens examination,urine analysis for salt intake estimation,blood pressure measurements |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The HT and control groups were subdivided into age groups of < 50, 50-59, 60-69, and ≥ 70 years. These age groups comprised 54, 109, 80, and 62 patients in the HT group and 19, 42, 42, and 21 patients in the control group, respectively.
Key inclusion criteria (1 listed)
- Salt Sensitivity Hypertension patients Non-SSH, salt-resistant HT (SRH) patients Control patients without HT, aged 40-80 years.
Key exclusion criteria (2 listed)
- Cataracts Diabetes Mellitus Smoking Hypo/hypercalcemia Hyperparathyroidism Eye trauma Coronary artery disease Cardiac failure Renal failure
- -
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 |
|---|---|---|
| Lens examinationAlso: urine analysis for salt intake, Blood pressure measurementsThe presence of cortical lens opacity was biomicroscopically examined by two researchers using the diffuse, direct, Scheimpflug and retroillumination from the fundus methods. | Diagnostic test | Control group, Salt resistance group, Salt-sensitive group |
Primary outcome
Lens examination
Time frame: 6 months
Biomicroscopic lens examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Individual participant dataSharing planned: No
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.
Şahbender Koç, Cardiologist principal investigator
Keçiören Education and Training Hospital
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 Salt Hypertension From Excess Dietary Salt and Lens Opacities, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 29 Dec 2017. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lens examination (time frame: 6 months). 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 29 Dec 2017.