2024-512544-27-00已完成4 期
Treatment of vascular stiffness in patients with autosomal dominant polycystic kidney disease
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年5月24日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The three primary outcomes of this study are the differences in pulse wave velocity (PWV) in high salt versus placebo group, and before versus after amiloride treatment in both groups.
研究概览
简要总结
We aim to determine if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD and whether treatment with amiloride prevents these effects. We divided the main objective into three sub-objectives:
- To determine if arterial stiffness is exacerbated due to a high-salt diet in patients with ADPKD.
- To investigate whether amiloride treatment could reduce the effect of high salt on arterial stiffness in the group with salt supplement.
- To investigate whether treatment with amiloride further reduces arterial stiffness in the setting of a low-salt diet.
研究设计
- 分配方式
- Randomized
- 主要目的
- Intervention period (4 weeks)
- 盲法
- Double (Monitor, Investigator, Subject, Carer, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adults with typical ADPKD diagnosed based on Ravine criteria and/or a documented Pkd 1 or 2 mutation
- •CKD-EPI eGFR ≥60 ml/min/1.73m2
- •Ability to provide informed consent
排除标准
- •Uncontrolled hypertension, defined as an office blood pressure of ≥160/ ≥90 mmHg with or without antihypertensive treatment
- •Concomitant use of drugs that could influence blood pressure and/or disease progression (Tolvaptan/non-steroidal anti-inflammatory drugs (NSAIDs)/chemotherapy), excluding £ 2 antihypertensive drugs
- •Actual pregnancy or unwillingness to adhere to reproductive precautions during the duration of the study
- •Concomitant use of ≥ 3 antihypertensive medications
- •When antihypertensive treatment is prescribed for any other treatment indication than hypertension (e.g. cardia arrhythmia)
- •Serum potassium levels >5.5 mmol/L (measured within last 6 months)
- •History of liver disease (excluding liver cysts due to ADPKD)
- •History of heart failure (cardiac ejection fraction < 35%) or cardiac arrhythmia
- •History of diabetes mellitus
- •Active infection or antibiotic therapy
- •Immunosuppressive therapy within the last year
结局指标
主要结局
The three primary outcomes of this study are the differences in pulse wave velocity (PWV) in high salt versus placebo group, and before versus after amiloride treatment in both groups.
The three primary outcomes of this study are the differences in pulse wave velocity (PWV) in high salt versus placebo group, and before versus after amiloride treatment in both groups.
次要结局
- Ambulatory (24-hours) blood pressure measurements
- Serum markers of inflammation
- Other relevant serum markers for inflammation and endothelial dysfunction
- 23Na-MRI scans measuring interstitial sodium accumulation in a subgroup of patients
- Salt tasting sensitivity
研究者
M. Salih
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary SurgeryHyponatremiaNCT07273630University Hospital, Basel, Switzerland282
已完成
不适用
Can Cocoa Flavanols Protect Endothelial Function During Prolonged Sitting in Healthy Older Adults?HealthyNCT07265869University of Birmingham20
尚未招募
不适用
Carotid Doppler Screening for Subclinical Atherosclerosis in Diabetic CKD Patients.Diabetes Mellitus, Type 2Chronic Kidney DiseaseAtherosclerosisNCT07266220Abdallah Ali Mohammed96
招募中
3 期
A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)Ankylosing SpondylitisNCT07261644Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.500
招募中
3 期
Specifying the Anti-inflammatory Effects of Ziltivekimab (SPIDER)2024-515893-29-01Stichting Amsterdam UMC40