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

NCT05040516 | Unknown

• 1 other identifier: KB-39/2020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Obstructive Sleep Apnea

Keywords

hypertension; renalase; selenoprotein

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Assesment of Blood Total Antioxidant Status (TAS)

  One day

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• arterial hypertension

You may not qualify if:

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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Department of Hygiene, Wroclaw Medical University

Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10 ml of venous blood collected by venopuncture

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Paweł Gać, ASSOC PROF

  Wroclaw Medical University

  STUDY CHAIR

Central Study Contacts

Karolina Czerwińska, MD

CONTACT

+48 790 404 619; karolina.czerwinska@student.umed.wroc.pl

Paweł Gać, ASSOC PROF

CONTACT

+48 71 784 15 01; pawel.gac@umed.wroc.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 10, 2021
• Study Start: January 27, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)