Clinical Research Directory

Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study

For many years, people with moderate to advanced chronic kidney disease (CKD) have been advised to limit their intake of potassium, a mineral found in many foods such as fruit, vegetables, legumes, whole grains, and nuts. The reason for this has been the risk of hyperkalemia, a condition in which the potassium level in the blood becomes too high and can be dangerous. In recent years, however, this view has been questioned. New research suggests that the link between potassium in food and high potassium levels in the blood may not be as clear as previously thought. People who follow a strict potassium-restricted diet experience a lower quality of life and less satisfaction with their dietary treatment. At the same time, they miss out on the health benefits of eating a varied and nutritious diet. Today, many experts advocate a more individualized approach to potassium intake: instead of generally restricting potassium, the goal should be to maintain normal potassium levels in the blood, while encouraging a healthy diet. However, this message is not always clear in healthcare, and many people therefore continue to avoid potassium-rich foods altogether. The result is that they eat fewer natural ingredients and instead consume more processed and ultra-processed foods. Such foods can be more harmful, partly because they often contain potassium additives that are absorbed effectively by the body and their quantities are not reported in the nutritional label. This "hidden" potassium can contribute more to high potassium levels in the blood than the potassium that occurs naturally in plant-based foods. In addition, potassium from whole plant-based foods is absorbed more slowly, partly due to its fiber content. Plant-based diets may also have other positive effects for people with kidney disease: they can contribute to reduced blood acidity, known as metabolic acidosis, healthier gut flora, lower levels of inflammation, and reduced phosphorus intake. Together, these factors can counteract several of the metabolic complications associated with kidney disease. In a previous study, our research group showed that even patients with advanced kidney disease (CKD stage 4-5) and already elevated potassium levels could follow a healthy plant-based diet if they also used a potassium-binding drug (sodium zirconium cyclosilicate, SZC). This enabled them to eat more fruit, vegetables, and legumes, while also experiencing improved quality of life. The current study builds on these results and is planned as a pilot study in which patients with moderate to advanced kidney disease, but who are not yet being treated with dialysis, are assigned to two different dietary strategies for six months: * Healthy plant-based diet (healthy-PBD): a more liberal and balanced plant-based diet without specific potassium restrictions. * Potassium-restricted plant-based diet (restricted-PBD): a traditional plant-based diet with restrictions on potassium-rich foods, according to current standard recommendations. The main purpose is to investigate whether the healthy plant-based diet leads to more or more severe cases of hyperkalemia than the restricted diet. Our hypothesis is that potassium levels may increase slightly in the group with a liberal diet, but not to dangerous levels. The study will also examine secondary outcomes, such as quality of life, satisfaction with treatment, and how well patients accept the diet. In addition, taste experiences will be tested with taste strips (sweet, sour, salt, bitter and umami) before and after the intervention in both groups. If this pilot study shows that a healthier and less restrictive diet is safe, it could pave the way for a larger study investigating the long-term metabolic effects of a plant-based diet in kidney care.

Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.

Hyperkalemia Quality Improvement Program (HK-QIP) Study

This is a prospective, multi-center, single-arm study to evaluate the impact of implementation of guideline determined medical therapy (GDMT) for quality control improvement in non-dialysis chronic kidney disease (CKD-ND) patients, as well as provide evidence for standard hyperkalemia management with RAASi optimization in China CKD-ND patients.

Adding Urea to the Final Dialysis Fluid

At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.

Potassium Supplementation in CKD

The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate \[eGFR\] 15 - 45 ml/min/1.73 m2).

Observational Study on the Prevalence and Risk Factors of Patients With Hyperkalaemia in Brazil

This is a descriptive, retrospective study involving patients from private cardiology, nephrology, and dialysis clinics in Brazil who participated in the National Hyperkalaemia Diagnosis Campaign. The study used anonymised data from the Hi Technologies Ltda. database. The objective was to estimate and characterise the prevalence of hyperkalaemia (HK), as well as to analyse the demographic profile, clinical characteristics, risk factors and treatment patterns associated with total blood potassium levels.

Dietary Potassium Liberalization in Pre-Dialysis Patients

The study will look at the impact of the potassium content in fruits and vegetables, on serum potassium concentrations in people with Chronic Kidney Disease (CKD) using a randomized crossover design. Participants will receive home delivery of fruit and vegetables with either higher or lower potassium content in a random order. Clinical chemistry markers from blood and urine samples, blood pressure, physical functioning and health related quality of life will be assessed throughout the duration of the trial. This study will also measure their physical functioning, using a chair stand test. The results of this study could change the dietary recommendations for people with CKD related to potassium.

Potassium Correction for RAAS Optimization in Chronic Kidney Disease

The goal of this placebo-controlled, double-blinded cross-over trial is to test whether patiromer, compared with placebo, better enables up-titration of RAAS-blocker treatment in patients with chronic kidney disease stage 3b/4. The main questions it aims to answer are: * Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in albuminuria and blood pressure? * Does patiromer allow uptitration of irbesartan, resulting in a significant reduction in blood pressure? The trial contains the following interventions: * Participants will be switched from their ACEi/ARB to a standardised dose of irbesartan (150 mg/d). * During two 12-week study periods, participants will receive either patiromer 8.4 g/d or placebo. The order of study periods is randomized. * At the start of each study period irbesartan will be up-titrated to 300 mg/d. * After 1 and 6 weeks, at both periods, plasma potassium will be measured and the irbesartan dose will be reduced to 150 mg/d in case plasma potassium exceeds 5.0 mmol/L. * At 12 weeks from the start of the study period, the endpoints will be assessed. * Between the two study periods, there is a 6-week washout. Irbesartan dose during the wash-out period will be 150mg/d. After washout, participants will switch from the patiromer arm to the placebo arm or vice versa.

A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia

This clinical trial consists of 2 parts, Part A and Part B. Part A consists of a 2-day randomized, double-blind, placebo-controlled corrective phase (CP) and a 28-day randomized, double-blind, placebo-controlled maintenance phase (MP). Part B (open-label extension, OLE) is an open-label, 11-month extension study carried out in participants who come from Part A and meet certain inclusion criteria.

AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring

The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with chronic kidney disease (CKD). Study objectives are: * Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol/L) at the time of an outpatient laboratory draw. * Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.

Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community

The goal of this observational study is to investigate the prevalence and risk factors of hyperkalemia in community-based non-dialysis chronic kidney disease (CKD) patients. The main questions it aims to answer are: 1. What is the prevalence of hyperkalemia in non-dialysis CKD patients in a primary care setting? 2. What are the key risk factors influencing the occurrence of hyperkalemia in this population? Researchers will collect clinical and demographic data from participants across 18 community health centers and use both point-of-care testing (POCT) and laboratory-based methods to measure serum potassium levels and related parameters. Participants will: 1. Provide blood samples for POCT and laboratory testing. 2. Participate in interviews or questionnaires to gather clinical and lifestyle information. The findings will be used to construct a risk prediction model for hyperkalemia, aiming to optimize screening pathways and improve disease management strategies in primary care.

OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure

Mineralocorticoid receptor antagonists (MRA) is one of cornerstones in the treatment of heart failure with reduced ejection fraction (HFrEF). However, MRA has been extremely under-used globally. The main reason for this seems to be increased risk of hyperkalemia in individuals on MRA. Theoretically, by limiting the risk of hyperkalemia it could thus be possible to optimize MRA therapy. This is studied in this randomized controlled trial in which it is investigated whethere adding a potassium-binder in combination with MRA treatment prevent hyperkalemia to a greater extent than only using MRA. The specific aim of this study is to demonstrate the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC) in optimizing MRA in symptomatic patients with HFrEF. A multicenter, randomized, placebo-controlled, double-blinded study in Sweden (n=110) The study consists of 2 phases: 1) open-label run-in within maximum 2 months, where all are treated with SZC to test tolarability, and 2) a 1:1 randomized, double-blinded and placebo-controlled treatment during 6 months. The open-label phase, in turn, consists of three periods: run-in (1 - 2 weeks), correc-tion (maximum 72 hours) and maintenance (4-7 weeks). In addition, post-randomization phase, all patients will be followed by 3 visits (Follow-Up 1, 2 and 3) at 1, 2 and 4 weeks after End of Study (EOS) / End of Treatment (EOT) (which comes first) for further control of kalium and creatinine levels and documentation of current MRA use incl dose. Sodium Zirconium Cyclosilicate (SZC) (Lokelma)®, 5 g, 10 g, orally, is an approved drug in Sweden. For correction of hyperkalemia, the recommended starting dose is 10 g, three times daily. Once normokalemia has been achieved, the maintenance reg-imen should be started with 5 g once daily. The dose can be titrated up to 10 g once daily or lowered to 5 g once every other day as needed, to maintain a normal level of potassium. Primary Objective: To demonstrate the efficacy of Sodium Zirconium Cyclosilicate (SZC) on optimiz-ing MRA in HFrEF, SZC vs Placebo. Outcome measure: Whether a patient maintains MRA either at a dose ≥ 25 mg daily (for those without MRA at base-line) or a dose increase by 25 mg daily (for those with MRA ≤ 25 mg daily at baseline) and K level in the normal range (3.5-5.0 mmol/L) at the end of study, without rescue therapy due to hy-perkalemia at any point during the randomization phase.

Targeted Potassium Levels for Prevention of ICD Therapy

This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower incidence of cardiac arrhythmias in patients with an ICD. Patients will be randomized to this treatment or a control arm, where patients will receive usual guideline recommended follow-up.

Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4

Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease. Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \[1\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD. Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi). Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \> 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed

COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable

The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using AI-based software (CardioMIND and CardioQSync). The study devices offer non-invasive, multiplexed, AI-enabled direct-from-ECG detection as a novel alternative to traditional diagnostic methods, including imaging, hemodynamic monitoring systems, catheter-based devices, and biochemical assays. Continuous COR ECG data collected in hospital, outpatient clinic, or home settings will be analyzed to evaluate the predictive accuracy, sensitivity, specificity, and performance of these devices in differentiating between screen-positive and screen-negative subjects. The panel of screened indications encompasses a broad spectrum of clinically relevant cardiovascular, cardiopulmonary, and sleep-related diagnostic parameters, which are critical for advanced patient assessment and management. In the cardiovascular domain, the protocol emphasizes the detection and classification of heart failure, assessment of ejection fraction severity, and identification of myocardial infarction, including pathological Q-waves and STEMI. It further addresses diagnostic markers for arrhythmogenic conditions such as QT interval prolongation, T-wave alternans, and ventricular tachycardia, as well as insights into ischemia, atrial enlargement, ventricular activation time, and heart rate turbulence. Additional parameters, such as heart rate variability, pacing efficacy, electrolyte imbalances, and structural abnormalities, including left ventricular hypertrophy, contribute to comprehensive cardiovascular risk stratification. In the non-invasive cardiopulmonary context, the protocol incorporates metrics like respiratory sinus arrhythmia, cardiac output, stroke volume, and stroke volume variability, providing critical insights into hemodynamic and autonomic function. The inclusion of direct-from-ECG metrics for sleep-related disorders, such as the apnea-hypopnea index, respiratory disturbance index, and oxygen saturation variability, underscores the protocol's utility in addressing the intersection of cardiopulmonary and sleep medicine. This multifaceted approach establishes a robust framework for precision diagnostics and holistic patient management. The COR 1.0 and COR 2.0 wearables provide multi-lead ECG recordings, with COR 2.0 offering extended capabilities for cardiopulmonary metrics and longer battery life (up to 14 days). COR 2.0 supports tri-modal operations: (i) Extended Holter Mode: Outputs Leads II and III, mirroring the functionality of COR 1.0 for broader ECG monitoring applications. (ii) Cardiopulmonary Mode: Adds real-time recording of Lead I, V2, respiratory impedance, and triaxial accelerometer outputs, providing advanced cardiopulmonary insights. (iii) Real-Time Streaming Mode: Streams data directly to mobile devices or computers via Bluetooth Low Energy (BLE), enabling real-time waveform rendering and analysis. The COR 2.0 units are experimental and not yet FDA-cleared. Primary endpoints include sensitivity (true positive rate) \> 80%, specificity (true negative rate) \> 90%, and statistical agreement with reference devices for cardiovascular, cardiopulmonary, and sleep metrics. Secondary endpoints focus on predictive values (PPV and NPV) and overall diagnostic performance. The study employs eight distinct sub-protocols (A through H) to address a variety of cardiovascular, cardiopulmonary, and sleep-related diagnostic goals. These sub-protocols are tailored to specific clinical endpoints, varying in duration (30 minutes to 14 days) and type of data collection. Up to 15,000 participants will be enrolled across multiple sub-protocols. Screening ensures eligibility, and subjects must provide informed consent before participation. Dropouts and non-compliant subjects will be excluded from final analyses.

the Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

The management of serum potassium in maintenance hemodialysis（MHD ）patients is one of the hot topics at present. In order to control hyperkalemia in dialysis patients, the use of hypokalemic dialysate is the most important measure to reduce potassium. This measure effectively reduces serum potassium, but increases the risk of hypokalemia after dialysis, which increases the risk of all-cause death in patients. Hyperkalemia and hypokalemia during and at the end of dialysis are important factors for arrhythmia and death in MHD patients. Due to the intermittent nature of hemodialysis treatment, MHD patients often experience frequent fluctuations in serum potassium, which is a potential risk factor for poor prognosis of MHD patients. Serum potassium variability can better reflect the potassium homeostasis in MHD patients. In addition to hyperkalemia and hypokalemia, serum potassium variability is a potential risk factor affecting the prognosis of MHD patients. At present, there are few studies on the effect of improving serum potassium variability on cardiovascular complications, especially multi-center randomized controlled trials. In this study, sodium zirconium cyclosilicate was used to control hyperkalemia before dialysis and increase potassium concentration in dialysate, so as to reduce the risk of hypokalemia after dialysis, and to verify whether improving serum potassium variability can reduce myocardial injury in hemodialysis patients.

Lower Vs. Standard Insulin-Dextrose Doses for Treating Mild to Moderate Hyperkalemia in the Emergency Department

This clinical trial aims to evaluate the safety and efficacy of a lower dose insulin compared to the conventional dose for treating mild to moderate hyperkalemia, a condition characterized by elevated serum potassium levels below 6.4 mmol/L. The study focuses on adult patients in the emergency department. The primary objective is to determine whether the efficacy of lower doses of insulin and dextrose is non-inferior to conventional doses in reducing serum potassium levels in patients with mild to moderate hyperkalemia. The research compares two regimens: 5 units of insulin with 25 mL of dextrose 50% versus 10 units of insulin with 50 mL of dextrose 50%, assessing the mean reduction in serum potassium levels, the incidence of hypoglycemia, and the risk of extravasation injury. Participants will be monitored in the emergency department for 6 hours. Serum potassium levels will be measured at 1, 2, 4, and 6 hours post-intervention, while blood glucose levels will be monitored at 30, 60, 90, 120, 240, 300, and 360 minutes post-intervention.

Chronic Kidney Disease, Hyperkalemia and Echocardiographic Changes

Patients with CKD ( eGFR \< \<60 mL/min/1,73 m2) presenting to emergency department with isolated hyperkalemia will be study population. Pre and post treatment ECG and echocardiographic findings will be recorded. Investigator will not intervene with the treatment decision of responsible physician and will not delay any intervetion or treatment for the sake of study. Data will be compared in terms of ECHO and ECG findings depending on hyperkalemia level and response to treatment.

Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia

Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure. Globally, the reported incidence of hyperkalemia varies from 1.1 to 10 per 100 hospitalizations, depending on the patient cohort and comorbidities. Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated. Several studies have established the association between hyperkalemia and all-cause mortality. Because of the deleterious cardiac effects of hyperkalemia, its management is an emergency intervention. However, robust evidence is lacking to guide the emergency management of patients with hyperkalemia. Emergency treatment approaches are largely based on small studies, anecdotal experience, and traditionally accepted practice patterns within institutions. Therefore, a rigorous evaluation of the first-line treatments of hyperkalemia in emergency departments is needed and a large scale randomized clinical trial is warranted before robust recommendations for clinical practice can be made. Our clinical trial will improve the safety of patients with acute hyperkalemia and will help clinicians in their day by day practice to choose the treatment that significantly reduces morbidity and mortality during acute hyperkalemia management. Our results will be delivered in a timely fashion, owing to the high prevalence of hyperkalemia in the emergency department setting and to the commitment of the INI-CRCT network of Excellence, along with ED specialists used to work jointly. the primary objective of our trial is to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of nebulized salbutamol and insulin/dextrose intravenous infusion to reduce serum potassium concentration at 60 minutes, as first-line treatment, in emergency departments.