- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04023214
The Role of Endothelial Dysfunction in Adult Polycystic Kidney Disease
Endothelial Dysfunction in Autosomal Dominant Polycystic Kidney Disease
연구 개요
상세 설명
Following recruitment we will record the following baseline demographics; age, gender, smoking status, body mass index, medical history.
Participants will undergo a noninvasive vascular assessment, venepuncture and will provide a urine sample.This will be done during a single visit to the CRF.
Noninvasive vascular assessment will consist of:
Peripheral Arterial Tonometry This will be measured using the EndoPAT system (Itamar Medical)
Endothelial shear stress flow stimulus will be provided by inflation of a blood pressure cuff around the upper non-dominant arm to suprasystolic pressure (but <300mmHg) for 5 minutes. Following release of the cuff the resulting digital microcirculation vasodilatory response to ischaemic hyperaemia, quantified as the pulse wave amplitude, will be monitored over 5 minutes. The peak pulse wave amplitude measured at 90-150s post cuff deflation relative to baseline will be indexed to the changes in the opposite arm to give the reactive hyperaemia index. This measure of endothelial function constitutes the outcome measure.
- Blood Pressure Assessment Brachial artery blood pressure will be measured in the left arm in the supine position using an automated device (Dinamap) and in accordance with the clinical research facility SOP.
- Blood samples and urine samples
Samples for plasma will be centrifuged and stored at -80C. Biochemical analysis will be performed by the laboratory of the STH NHS Trust for standard tests and by validated assays for non-routine markers (as detailed below) in the Academic Nephrology Unit.
Participants will be asked to collect a 24h urine sample from the day before the study visit and to provide a spot urine sample on the day. This will be analysed at the laboratory of the STH NHS Trust.
Biochemical Analysis
Serum samples will be analyzed for Full blood count, Urea, Electrolytes, Glucose, Insulin, Lipid Profile, Homocysteine, (Hs) CRP and Creatinine Levels.
Serum and plasma will also be stored for future analysis of relevant biomarkers of endothelial function or nitric oxide metabolism as indicated by preliminary results.
Urine samples will be analysed initially for protein creatinine ratio (PCR). The rest will be frozen for future analysis of urinary biomarkers of endothelial function or nitric oxide metabolism.
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age >18yrs, <50yrs
- Able to understand spoken/written English sufficiently to give informed consent and to take part in clinical assessment
- Clinical diagnosis of ADPKD
- eGFR >60ml/min/1.73m2
Exclusion Criteria:
- No history of cardiovascular disease or hypertension
- Not diabetic
- Not smoking
- Not breastfeeding
- Not pregnant
- Not taking any regular medication (except oral contraceptives)
- No musculoskeletal conditions contraindicating inflation of a blood pressure cuff to suprasystolic pressures around the forearm (as part of EndoPAT measurements)
- Not morbidly obese: BMI<35 (May contribute to endothelial dysfunction)
- eGFR <60ml/min/1.73m2
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
통제 수단
건강한 자원봉사자
|
This will be measured using the EndoPAT system (Itamar Medical)
|
ADPKD
ADPKD patients
|
This will be measured using the EndoPAT system (Itamar Medical)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Reactive hyperemia index (RHI)
기간: Baseline
|
EndoPAT values (Endoscore)
|
Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Systolic and diastolic Blood pressure
기간: Baseline
|
mm Hg
|
Baseline
|
Proteinuria
기간: Baseline
|
Protein creatinine ratio
|
Baseline
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Albert Ong, STH
- 연구 책임자: Timothy Chico, STH
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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. .
Peripheral (digital) arterial tonometry에 대한 임상 시험
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Vanderbilt University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)완전한