THE USE OF POTASSIUM-RICH SALT SUBSTITUTES IN BLOOD PRESSURE CONTROL OF KIDNEY TRANSPLANT RECIPIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hyperkalemia
研究概览
简要总结
Excessive sodium intake and inadequate potassium intake in the diet are known risk factors for the development of arterial hypertension and an increased risk of cardiovascular events. Data from randomized controlled trials show that the use of salt substitutes with reduced sodium and increased potassium content represent an effective way to reduce dietary sodium intake, blood pressure and the occurrence of cardiovascular events. Patients adhere well to the use of salt substitutes as they do not have to change their daily cooking and seasoning habits and the taste is comparable to that of regular salt. The World Health Organization (WHO) also suggests the use of salt substitutes as an acceptable strategy for reducing dietary salt intake and thus lowering blood pressure and the burden of cardiovascular disease. Recommendations for the use of salt substitutes are not uniform, primarily because of the potential risk of adverse events with increased potassium intake in some individuals, such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics, and patients receiving potassium supplements.
Nephrology guidelines rarely comment on the use of potassium-rich salt substitutes or discourage their use in patients with advanced stage 4 and 5 CKD, with the exception of Chinese guidelines, which mention the use of potassium-rich salt substitutes in CKD patients not on dialysis depending on serum potassium levels. CKD patients have largely been excluded from clinical trials of potassium-rich salt substitutes, so there is insufficient data on their safety and efficacy in CKD patients.
In this randomized controlled trial, we will investigate the effects of using potassium-enriched salt substitutes on blood pressure control and serum potassium levels in kidney transplant recipients. In the intervention group, patients will use potassium-enriched salt substitutes at home in a ratio of 75% sodium chloride and 25% potassium chloride instead of regular table salt (100% sodium chloride) for cooking and seasoning food. In the control group, patients will use regular salt at home for cooking and seasoning food. The intervention and control groups will each include 40 to 50 patients who will be monitored for 12 weeks. The study's main focus will be the change in serum potassium and blood pressure before and after the intervention.
We expect to confirm the positive effects of potassium-enriched salt substitutes on blood pressure in kidney transplant recipients without causing undesirable hyperkalemia.
详细描述
Cardiovascular disease is the leading cause of morbidity and mortality worldwide, especially in patients with chronic kidney disease and kidney transplantation. Arterial hypertension is one of the most important risk factors for the occurrence of cardiovascular diseases. Despite advances in modern medicine, the treatment of arterial hypertension is often a major challenge, partly due to patients' poor adherence to medication and lifestyle changes, including adherence to dietary recommendations.
In addition to a reduced sodium intake, an increased potassium intake also plays an important role in lowering blood pressure. The mechanism of increased sodium intake in the development of high blood pressure is probably related to the inability of the kidneys to excrete excess sodium. Potassium deficiency leads to additional sodium retention as it stimulates the activation of the sympathetic nervous system and the renin-angiotensin-aldosterone system. Conversely, an increased potassium intake has the effect of reducing salt sensitivity. Increased potassium intake inhibits the phosphorylation of the NaCl cotransporter and simultaneously reduces sodium reabsorption in the proximal tubule and/or in the ascending limb of the loop of Henle.
Numerous epidemiological studies have shown an inverse relationship between potassium intake and blood pressure. The large international INTERSALT study showed that systolic blood pressure falls by an average of 2 to 3 mmHg when potassium intake is increased by 30 to 45 mmol/day. Reducing sodium intake and increasing potassium intake is likely to be an effective measure for treating arterial hypertension and cardiovascular disease in the population.
Recommendations for the use of salt substitutes to lower blood pressure and prevent cardiovascular disease are not uniform, primarily because of the potential risk of adverse events (especially hyperkalemia) with increased potassium intake in certain individuals such as patients with advanced chronic kidney disease (CKD), patients receiving potassium-sparing diuretics and patients receiving potassium supplements.
Nephrology guidelines rarely mention the use of potassium-rich salt substitutes or advise against it in patients with advanced CKD stages 4 and 5, with the exception of Chinese guidelines, which mention the use of potassium-enriched salt substitutes in non-dialysis CKD patients, depending on the serum potassium level. CKD patients have been mostly excluded from clinical studies of the use of potassium-enriched salt substitutes, so there is not enough data available for CKD patients on the safety and efficacy of potassium-enriched salt substitutes.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a transplanted kidney ≥ 3 months post kidney-transplant
- •a functioning transplanted kidney with estimated glomerular filtration rate (eGFR) according to CKD/EPI equation of at least 25 ml/min
- •Elevated blood pressure/hypertension at the time of examination at the Kidney Transplantation Center outpatient clinic, determined by standardized blood pressure measurement (RR ≥ 130/80 mmHg)
- •Age ≥ 18 years
排除标准
- •eGFR according to CKD/EPI equation below 25 ml/min
- •serum potassium > 5 mmol/l
- •history of unexplained hyperkalemia
- •pregnancy or planning of pregnancy
- •inability to provide informed consent or to participate in the study (mental retardation, psychiatric illness in an uncontrolled phase)
- •multiple organ transplantation
- •Consuming most of daily meals outside the home environment
结局指标
主要结局
Hyperkalemia
时间窗: 12 weeks.
Change in serum potassium in mmol/l after using potassium-enriched salt-substitutes for cooking and seasoning food at home for 12 weeks
次要结局
- Change in the urine sodium/potassium ratio(12 weeks)
- Change in taste of food(12 weeks)
- Change in average night diastolic blood pressure(12 weeks)
- Reduction in the number or dose of antihypertensive drugs(12 weeks)
- Change in systolic blood pressure(12 weeks)
- Change in diastolic blood pressure(12 weeks)
- Change in average systolic 24-hour blood pressure(12 weeks)
- Change in average diastolic 24-hour blood pressure(12 weeks)
- Change in average daily systolic blood pressure(12 weeks)
- Change in average daily diastolic blood pressure(12 weeks)
- Change in average night systolic blood pressure(12 weeks)
研究者
Tanja Belčič Mikič
MD, PhD, FEBTM
University Medical Centre Ljubljana