NCT03385070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
429

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

December 20, 2017

Last Update Submit

December 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lens examination

    Biomicroscopic lens examination

    6 months

Study Arms (3)

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

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

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

Interventions

Lens examinationDIAGNOSTIC_TEST

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

Also known as: urine analysis for salt intake, Blood pressure measurements
Control groupSalt resistance groupSalt-sensitive group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences.Keçiören Education and Training Hospital

Ankara, 06400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cataract

Interventions

UrinalysisBlood Pressure

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative TechniquesVital SignsPhysical ExaminationHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Şahbender Koç, Cardiologist

    Keçiören Education and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardıologıst

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

March 15, 2017

Primary Completion

December 7, 2017

Study Completion

December 7, 2017

Last Updated

December 29, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations