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

The Role of Selenoprotein Activity and Blood Renalase Level in the Pathogenesis of Hypertension and Obstructive Sleep Apnea

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Obstructive Sleep Apnea

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Karolina Czerwińska, MD; Phone Number: +48 790 404 619; Email: karolina.czerwinska@student.umed.wroc.pl
• Study Contact Backup: Name: Paweł Gać, ASSOC PROF; Phone Number: +48 71 784 15 01; Email: pawel.gac@umed.wroc.pl

Study Locations

• Poland
  • Dolnośląskie
    • Wrocław, Dolnośląskie, Poland, 50-368
      • Recruiting
      • Department of Hygiene, Wroclaw Medical University
      • Contact: Paweł Gać, ASSOC PROF; Phone Number: +48 71 784 15 01; Email: pawel.gac@umed.wroc.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study participants will be recruited among the patients of the Department of Internal and Occupational Diseases, Hypertension and Clinical Oncology in Wroclaw. 150 more consecutive patients with hypertension and obstructive sleep apnea will be included in the planned observational study.

Description

Inclusion Criteria:

• arterial hypertension

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Group 1; 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 and echocardiography. A 10 ml of venous blood sample will be collected by venopuncture. Laboratory tests will be performed using commercially available standardized tests.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assesment of Blood Total Antioxidant Status (TAS)	The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)	One day

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Study Chair: Paweł Gać, ASSOC PROF, Wroclaw Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: hypertension; selenoprotein; renalase
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea
• Other Study ID Numbers: KB-39/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No