Selenoprotein and Renalase Blood Levels in Patients With Hypertensive Heart Disease and Obstructive Sleep Apnea

• Conditions: Obstructive Sleep Apnea; Hypertension

• Registration Number: NCT05040516
• Lead Sponsor: Wroclaw Medical University

Brief Summary

The aim of the study is to determine whether selenoprotein activity and blood renalase level correlate with subclinical hypertensive heart disease and obstructive sleep apnea. The correlation will be assessed using selected electrocardiographic, ultrasound and laboratory indicators.

Detailed Description

The study will be conducted in the Department and Clinic of Internal Medicine, Occupational Diseases, Hypertension and Clinical Oncology at Borowska 213 street in Wroclaw. This decision follows the high percentage of people with obstructive sleep apnea and hypertension among those hospitalized in the Clinic and also the wide availability of research tools in the hospital.

150 more patients with hypertension and obstructive sleep apnea will be included in the planned observational study.

The study is observational, research procedures are non-invasive and no additional medical experiment is planned. The study was approved by the Bioethics Committee of the Wroclaw Medical University.

Patients enrolled in the study will be asked to share the results of their previously performed examinations or, in case they do not have any, new examinations will be performed to complement the diagnostic process of hypertension and obstructive sleep apnea.

The planned procedures include: medical interview, physical examination with basic anthropometric measurements (age, height, body weight); biochemical tests including blood selenium, selenoproteins, renalase and creatinine levels; total antioxidant status (TAS), 24-hour Holter electrocardiography, polysomnography, ultrasound assessment of peripheral vascular endothelial function and echocardiography.

Laboratory tests will be performed using commercially available standardized tests. The levels of selenoproteins, renalase and creatinine in the blood, as well as TAS will be determined by ELISA (Enzyme-linked immunosorbent assay) in accordance with the instructions. Blood selenium level will be measured by means of atomic absorption spectrometry (AAS). 24-hour Holter ECG monitoring will be performed using a Lifecard CF recorder, followed by an analysis of the record by the Impresario Solo system (Delmar Reynolds, Hertford, UK). Ultrasound examination will be performed using the ProSound Alpha 6 (Aloka Inc, Tokyo, Japan).

Study Timeline

• Study Start: 2020-01-27
• Status Verified: 2021-08
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-10
• Last Update Posted: 2021-09-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• arterial hypertension

Exclusion Criteria

• age <18
• pregnancy
• refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of arrhythmias and cardiac morphology	One day	Echocardiography
Assesment of blood renalase level	One day	The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level
Assesment of the severity of obstructive sleep apnea	One day	Full polysomnography
Assessment of arrhythmias	One day	24-hour Holter ECG monitoring
Assesment of blood selenoprotein P level	One day	The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level

Secondary Outcome Measures

Name	Time	Method
Assesment of Blood Total Antioxidant Status (TAS)	One day	The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)

Trial Locations

Locations (1)

Department of Hygiene, Wroclaw Medical University; 🇵🇱 Wrocław, Dolnośląskie, Poland