- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Karolina Czerwińska, MD
- Telefonnummer: +48 790 404 619
- E-post: karolina.czerwinska@student.umed.wroc.pl
Studera Kontakt Backup
- Namn: Paweł Gać, ASSOC PROF
- Telefonnummer: +48 71 784 15 01
- E-post: pawel.gac@umed.wroc.pl
Studieorter
-
-
Dolnośląskie
-
Wrocław, Dolnośląskie, Polen, 50-368
- Rekrytering
- Department of Hygiene, Wroclaw Medical University
-
Kontakt:
- Paweł Gać, ASSOC PROF
- Telefonnummer: +48 71 784 15 01
- E-post: pawel.gac@umed.wroc.pl
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- arterial hypertension
Exclusion Criteria:
- age <18
- pregnancy
- refusal to participate in the study
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Tvärsnitt
Kohorter och interventioner
Grupp / 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assesment of blood renalase level
Tidsram: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level
|
One day
|
Assesment of blood selenoprotein P level
Tidsram: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level
|
One day
|
Assesment of the severity of obstructive sleep apnea
Tidsram: One day
|
Full polysomnography
|
One day
|
Assessment of arrhythmias
Tidsram: One day
|
24-hour Holter ECG monitoring
|
One day
|
Assessment of arrhythmias and cardiac morphology
Tidsram: One day
|
Echocardiography
|
One day
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assesment of Blood Total Antioxidant Status (TAS)
Tidsram: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)
|
One day
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Paweł Gać, ASSOC PROF, Wroclaw Medical University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KB-39/2020
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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