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
調査の概要
詳細な説明
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).
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Karolina Czerwińska, MD
- 電話番号:+48 790 404 619
- メール:karolina.czerwinska@student.umed.wroc.pl
研究連絡先のバックアップ
- 名前:Paweł Gać, ASSOC PROF
- 電話番号:+48 71 784 15 01
- メール:pawel.gac@umed.wroc.pl
研究場所
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Dolnośląskie
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Wrocław、Dolnośląskie、ポーランド、50-368
- 募集
- Department of Hygiene, Wroclaw Medical University
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コンタクト:
- Paweł Gać, ASSOC PROF
- 電話番号:+48 71 784 15 01
- メール:pawel.gac@umed.wroc.pl
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- arterial hypertension
Exclusion Criteria:
- age <18
- pregnancy
- refusal to participate in the study
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:ケースのみ
- 時間の展望:断面図
コホートと介入
グループ/コホート |
---|
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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Assesment of blood renalase level
時間枠:One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level
|
One day
|
Assesment of blood selenoprotein P level
時間枠:One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level
|
One day
|
Assesment of the severity of obstructive sleep apnea
時間枠:One day
|
Full polysomnography
|
One day
|
Assessment of arrhythmias
時間枠:One day
|
24-hour Holter ECG monitoring
|
One day
|
Assessment of arrhythmias and cardiac morphology
時間枠:One day
|
Echocardiography
|
One day
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Assesment of Blood Total Antioxidant Status (TAS)
時間枠:One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)
|
One day
|
協力者と研究者
捜査官
- スタディチェア:Paweł Gać, ASSOC PROF、Wroclaw Medical University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。