Bicarbonate Administration in CKD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Change in Brachial Artery Flow Mediated Dilation
研究概览
简要总结
Low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death. The current proposal will investigate whether bicarbonate administration in patients with chronic kidney disease (CKD) will improve the health and function of arteries and reduce the size of the left ventricle of the heart. Overall, the proposed research will provide important new scientific evidence upon which physicians can base recommendations to patients with CKD to decrease the risk of developing cardiovascular diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years
- •Serum bicarbonate 22-25 mEq/L on 2 separate measurements (at least 1 day apart)
- •CKD stage 3B or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
- •Blood pressure <130/80 mm Hg prior to randomization
- •BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
- •Able to provide consent
- •Stable anti-hypertensive regimen for at least one month prior to randomization
- •Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).
排除标准
- •Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
- •Uncontrolled hypertension
- •Serum potassium < 3.3 or ≥ 5.5 mEq/L at screening
- •New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
- •Factors judged to limit adherence to interventions
- •Anticipated initiation of dialysis or kidney transplantation within 12 months
- •Current participation in another research study
- •Pregnancy or planning to become pregnant or currently breastfeeding
- •Chronic use of supplemental oxygen
- •Use of immunosuppression in past 3 months
- •Metal implant or implanted electrical device (patient will be unable to get MRI)
研究组 & 干预措施
Sodium Bicarbonate
Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
干预措施: Sodium bicarbonate (Drug)
Placebo
Subjects randomly assigned to placebo will take the same number of capsules as if they were assigned to receive 0.5 mEq/kg-LBW/day of sodium bicarbonate. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Brachial Artery Flow Mediated Dilation
时间窗: Measured at baseline and 12 months
Change in Aortic Pulse Wave Velocity
时间窗: Measured at baseline,12 months
次要结局
- Change in Left Ventricular Mass Index(Measured at baseline and 12 months)