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

• Sponsor: Wroclaw Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05040516
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 20.1
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 150 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: The Role of Selenoprotein Activity and Blood Renalase Level in the Pathogenesis of Hypertension and Obstructive Sleep Apnea
• Actual Study Start Date: Jan 27, 2020
• Anticipated Primary Completion Date: Oct 1, 2021
• Anticipated Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

1. Assesment of blood renalase level [One day]

   The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level

2. Assesment of blood selenoprotein P level [One day]

   The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level

3. Assesment of the severity of obstructive sleep apnea [One day]

   Full polysomnography

4. Assessment of arrhythmias [One day]

   24-hour Holter ECG monitoring

5. Assessment of arrhythmias and cardiac morphology [One day]

   Echocardiography

Secondary Outcome Measures

1. Assesment of Blood Total Antioxidant Status (TAS) [One day]

   The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• arterial hypertension

Exclusion Criteria:

• age <18

• pregnancy

• refusal to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hygiene, Wroclaw Medical University	Wrocław	Dolnośląskie	Poland	50-368

Sponsors and Collaborators

• Wroclaw Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wroclaw Medical University
• ClinicalTrials.gov Identifier: NCT05040516
• Other Study ID Numbers: KB-39/2020
• First Posted: Sep 10, 2021
• Last Update Posted: Sep 10, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wroclaw Medical University: hypertension; renalase; selenoprotein
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension

Study Results

No Results Posted as of Sep 10, 2021