- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05040516
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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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).
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Karolina Czerwińska, MD
- Telefonnummer: +48 790 404 619
- E-post: karolina.czerwinska@student.umed.wroc.pl
Studer Kontakt Backup
- Navn: Paweł Gać, ASSOC PROF
- Telefonnummer: +48 71 784 15 01
- E-post: pawel.gac@umed.wroc.pl
Studiesteder
-
-
Dolnośląskie
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Wrocław, Dolnośląskie, Polen, 50-368
- Rekruttering
- Department of Hygiene, Wroclaw Medical University
-
Ta kontakt med:
- Paweł Gać, ASSOC PROF
- Telefonnummer: +48 71 784 15 01
- E-post: pawel.gac@umed.wroc.pl
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- arterial hypertension
Exclusion Criteria:
- age <18
- pregnancy
- refusal to participate in the study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assesment of blood renalase level
Tidsramme: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level
|
One day
|
|
Assesment of blood selenoprotein P level
Tidsramme: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level
|
One day
|
|
Assesment of the severity of obstructive sleep apnea
Tidsramme: One day
|
Full polysomnography
|
One day
|
|
Assessment of arrhythmias
Tidsramme: One day
|
24-hour Holter ECG monitoring
|
One day
|
|
Assessment of arrhythmias and cardiac morphology
Tidsramme: One day
|
Echocardiography
|
One day
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assesment of Blood Total Antioxidant Status (TAS)
Tidsramme: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)
|
One day
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Paweł Gać, ASSOC PROF, Wroclaw Medical University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KB-39/2020
Plan for individuelle deltakerdata (IPD)
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