- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
정황
상세 설명
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).
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Karolina Czerwińska, MD
- 전화번호: +48 790 404 619
- 이메일: karolina.czerwinska@student.umed.wroc.pl
연구 연락처 백업
- 이름: Paweł Gać, ASSOC PROF
- 전화번호: +48 71 784 15 01
- 이메일: pawel.gac@umed.wroc.pl
연구 장소
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Dolnośląskie
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Wrocław, Dolnośląskie, 폴란드, 50-368
- 모병
- Department of Hygiene, Wroclaw Medical University
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연락하다:
- Paweł Gać, ASSOC PROF
- 전화번호: +48 71 784 15 01
- 이메일: pawel.gac@umed.wroc.pl
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- arterial hypertension
Exclusion Criteria:
- age <18
- pregnancy
- refusal to participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assesment of blood renalase level
기간: One day
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The Enzyme-linked immunosorbent assay (ELISA) to know blood renalase level
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One day
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|
Assesment of blood selenoprotein P level
기간: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know blood selenoprotein P level
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One day
|
|
Assesment of the severity of obstructive sleep apnea
기간: One day
|
Full polysomnography
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One day
|
|
Assessment of arrhythmias
기간: One day
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24-hour Holter ECG monitoring
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One day
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Assessment of arrhythmias and cardiac morphology
기간: One day
|
Echocardiography
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One day
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assesment of Blood Total Antioxidant Status (TAS)
기간: One day
|
The Enzyme-linked immunosorbent assay (ELISA) to know Blood Total Antioxidant Status (TAS)
|
One day
|
공동 작업자 및 조사자
수사관
- 연구 의자: Paweł Gać, ASSOC PROF, Wroclaw Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .