Salt Sensitivity Hypertension and Lens Opacities

Sponsor
Kecioren Education and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03385070
Collaborator
(none)
429
Enrollment
1
Location
8.8
Actual Duration (Months)
48.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: Lens examination

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
429 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Using Lens Opacities to Predict Salt Sensitivity Hypertension
Actual Study Start Date :
Mar 15, 2017
Actual Primary Completion Date :
Dec 7, 2017
Actual Study Completion Date :
Dec 7, 2017

Arms and Interventions

ArmIntervention/Treatment
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

Diagnostic Test: 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.
Other Names:
  • urine analysis for salt intake
  • Blood pressure measurements
  • 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

    Diagnostic Test: 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.
    Other Names:
  • urine analysis for salt intake
  • Blood pressure measurements
  • 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

    Diagnostic Test: 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.
    Other Names:
  • urine analysis for salt intake
  • Blood pressure measurements
  • Outcome Measures

    Primary Outcome Measures

    1. Lens examination [6 months]

      Biomicroscopic lens examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    -

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Health Sciences.Keçiören Education and Training HospitalAnkaraTurkey06400

    Sponsors and Collaborators

    • Kecioren Education and Training Hospital

    Investigators

    • Principal Investigator: Şahbender Koç, Cardiologist, Keçiören Education and Training Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keçiören Eğitim Araştırma Hastanesi, Cardıologıst, Kecioren Education and Training Hospital
    ClinicalTrials.gov Identifier:
    NCT03385070
    Other Study ID Numbers:
    • 8.3.2017/1325
    First Posted:
    Dec 28, 2017
    Last Update Posted:
    Dec 29, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 29, 2017