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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040516
• Other study ID #: KB-39/2020
• Status: Recruiting
• Start date: January 27, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: August 2021
• Source: Wroclaw Medical University
• Contact: Karolina Czerwinska, MD
• Phone: +48 790 404 619
• Email: karolina.czerwinska[@]student.umed.wroc.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• arterial hypertension

Exclusion Criteria:

• age <18

• pregnancy

• refusal to participate in the study

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Poland	Department of Hygiene, Wroclaw Medical University	Wroclaw	Dolnoslaskie

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assesment of blood renalase level	The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level	One day
Primary	Assesment of blood selenoprotein P level	The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level	One day
Primary	Assesment of the severity of obstructive sleep apnea	Full polysomnography	One day
Primary	Assessment of arrhythmias	24-hour Holter ECG monitoring	One day
Primary	Assessment of arrhythmias and cardiac morphology	Echocardiography	One day
Secondary	Assesment of Blood Total Antioxidant Status (TAS)	The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)	One day