Clinical trial NCT05040516: Selenoprotein and Renalase Blood Levels in Patients With Hypertensive Heart Disease and Obstructive Sleep Apnea
Official title: The Role of Selenoprotein Activity and Blood Renalase Level in the Pathogenesis of Hypertension and Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Obstructive Sleep Apnea
Keywords: hypertension
renalase
selenoprotein
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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).

Eligibility criteria: Inclusion Criteria:

* arterial hypertension

Exclusion Criteria:

* age \<18
* pregnancy
* refusal to participate in the study

Primary outcomes:
measure: Assesment of blood renalase level
timeFrame: One day
measure: Assesment of blood selenoprotein P level
timeFrame: One day
measure: Assesment of the severity of obstructive sleep apnea
timeFrame: One day
measure: Assessment of arrhythmias
timeFrame: One day
measure: Assessment of arrhythmias and cardiac morphology
timeFrame: One day
Secondary outcomes:
measure: Assesment of Blood Total Antioxidant Status (TAS)
timeFrame: One day
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Hygiene, Wroclaw Medical University
state: Dolnośląskie
Study officials:
affiliation: Wroclaw Medical University
name: Paweł Gać, ASSOC PROF
role: STUDY_CHAIR
References: