Salt Sensitivity Hypertension and Lens Opacities

NCT ID: NCT03385070

Last Updated: 2017-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 429 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2017-12-07

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.

Conditions

Salt Hypertension From Excess Dietary Salt; Lens Opacities

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Lens examination

Intervention Type: DIAGNOSTIC_TEST

The presence of cortical lens opacity was biomicroscopically examined by two researchers using the diffuse, direct, Scheimpflug and retroillumination from the fundus methods.

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

Lens examination

Intervention Type: DIAGNOSTIC_TEST

The presence of cortical lens opacity was biomicroscopically examined by two researchers using the diffuse, direct, Scheimpflug and retroillumination from the fundus methods.

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

Lens examination

Intervention Type: DIAGNOSTIC_TEST

The presence of cortical lens opacity was biomicroscopically examined by two researchers using the diffuse, direct, Scheimpflug and retroillumination from the fundus methods.

Interventions

Lens examination

The presence of cortical lens opacity was biomicroscopically examined by two researchers using the diffuse, direct, Scheimpflug and retroillumination from the fundus methods.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

urine analysis for salt intake; Blood pressure measurements

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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• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kecioren Education and Training Hospital

OTHER

Sponsor Role: lead

Responsible Party

Keçiören Eğitim Araştırma Hastanesi

Cardıologıst

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Şahbender Koç, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Keçiören Education and Training Hospital

Locations

University of Health Sciences.Keçiören Education and Training Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

8.3.2017/1325

Identifier Type: -

Identifier Source: org_study_id