Clinical trial NCT03385070: Salt Sensitivity Hypertension and Lens Opacities
Official title: Using Lens Opacities to Predict Salt Sensitivity Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salt Hypertension From Excess Dietary Salt
Lens Opacities
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 429
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Salt Sensitivity Hypertension patients Non-SSH, salt-resistant HT (SRH) patients Control patients without HT, aged 40-80 years.

Exclusion Criteria:

Cataracts Diabetes Mellitus Smoking Hypo/hypercalcemia Hyperparathyroidism Eye trauma Coronary artery disease Cardiac failure Renal failure

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Primary outcomes:
measure: Lens examination
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences.Keçiören Education and Training Hospital
Study officials:
affiliation: Keçiören Education and Training Hospital
name: Şahbender Koç, Cardiologist
role: PRINCIPAL_INVESTIGATOR
References: