Diuretic Tuner App for Chronic Kidney Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Diuretics
Disqualifiers: Dialysis, Dementia, Pregnancy, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This purpose of this study is to determine the effectiveness of a mobile phone application in helping to control body swelling in patients with kidney problems. The application will help in the day to day adjustments in diuretic medication dosing.
Participants in this study will have an application loaded on to their mobile phone by the study team and be taught how to use it over a 2 hour visit. Participants will need to check their blood pressure and weight daily and enter this information into the mobile phone application every day. Participants will need to follow daily instructions in their medication dosing provided by the application. There will be periodic blood testing. This will happen at 2 weeks, 90 days, and up to 4 other times if necessary. At the end of the study there is a 2 hour study visit during which participants will answer a survey. The total length of the study is 90 days.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you will need to follow daily instructions for diuretic medication dosing provided by the mobile app.
What data supports the effectiveness of the Diuretic Tuner App for Chronic Kidney Disease?
Loop diuretics, which are part of the treatment, are effective in increasing urine output and controlling blood pressure in patients with chronic kidney disease, especially when combined with other diuretics. They are commonly used to manage fluid overload and hypertension in these patients.
12345Is the Diuretic Tuner App safe for people with chronic kidney disease?
Thiazide and loop diuretics, which are part of the Diuretic Tuner App, have been used for over 60 years and are generally safe, but they can cause side effects like low sodium or potassium levels, especially in people with advanced kidney disease.
36789How is the Diuretic Tuner drug unique for treating chronic kidney disease?
The Diuretic Tuner app combines different types of diuretics (water pills) like loop, thiazide, and potassium-sparing diuretics, which can be tailored to individual needs, potentially offering a more personalized approach to managing fluid balance and blood pressure in chronic kidney disease patients compared to standard treatments.
3481011Eligibility Criteria
This trial is for adults with severe kidney disease or nephrotic syndrome who have swelling due to fluid overload. They must be able to use a smartphone app, weigh between 100-300 lbs, and not be at immediate risk of needing dialysis or have life-threatening low potassium or sodium levels.Inclusion Criteria
I have severe kidney issues with swelling in my body and weigh less without the swelling.
Exclusion Criteria
Your blood test shows low levels of potassium.
You are expected to live for less than 6 months.
The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use the Diuretic Tuner mobile application to adjust diuretic dosing based on daily weight and blood pressure inputs
90 days
1 initial visit (in-person), periodic blood testing at 2 weeks, 90 days, and up to 4 other times
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a survey on tool usability
4 weeks
1 visit (in-person) for survey completion
Participant Groups
The study tests a mobile app called Diuretic Tuner that guides daily diuretic dosing based on the patient's blood pressure and weight inputs. The goal is to manage body swelling in patients over a 90-day period with regular monitoring and final feedback via survey.
1Treatment groups
Experimental Treatment
Group I: Diuretic Tuner usersExperimental Treatment1 Intervention
The Diuretic Tuner is a mobile device application that integrates a patient's estimated dry weight and starting diuretic dose (both defined by a healthcare provider) with daily weights and blood pressures to provide individualized guidance to the patient in day-to-day adjustments to his or her diuretic regimen. In addition, the application generates a diary of daily weights, blood pressures, fluid intake, and medication compliance.
Diuretic Tuner is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Diuretics for:
- High Blood Pressure
- Edema
- Heart Failure
- Chronic Kidney Disease
- Liver Disease
🇺🇸 Approved in United States as Diuretics for:
- High Blood Pressure
- Edema
- Heart Failure
- Chronic Kidney Disease
- Liver Disease
🇨🇦 Approved in Canada as Diuretics for:
- High Blood Pressure
- Edema
- Heart Failure
- Chronic Kidney Disease
- Liver Disease
🇯🇵 Approved in Japan as Diuretics for:
- High Blood Pressure
- Edema
- Heart Failure
- Chronic Kidney Disease
- Liver Disease
🇨🇳 Approved in China as Diuretics for:
- High Blood Pressure
- Edema
- Heart Failure
- Chronic Kidney Disease
- Liver Disease
🇨🇭 Approved in Switzerland as Diuretics for:
- High Blood Pressure
- Edema
- Heart Failure
- Chronic Kidney Disease
- Liver Disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas SouthwesternDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Combination diuretic treatment in severe heart failure: a randomised controlled trial. [2019](a) To test the hypothesis that a fixed 3 day course of the combination of a thiazide and loop diuretic is as effective as more prolonged treatment in the management of severe resistant cardiac failure. (b) To compare two thiazide diuretics (bendrofluazide and metolazone) in combination with loop diuretics in the treatment of severe resistant cardiac failure.
Edema and principles of diuretic use. [2019]Diuretics have changed the approach to many disease and have turned once fatal conditions into tolerable ones. Treatment of salt and water overload and edema can be quite satisfying for the clinician as long as the patient is closely watched for side effects. Thiazide diuretics have their greatest use in hypertension, loop diuretics in edema and congestive heart failure, CA inhibitors in glaucoma and altitude sickness, potassium-sparing diuretics in hypokalemia induced by other diuretics and ascites, and osmotic diuretics in acute renal failure and dialysis. They are among the most widely prescribed medications in the world today and rightly have a prominent place in the armamentarium against disease.
Revisiting diuretic choice in chronic kidney disease. [2023]Existing guidelines offer little direction about the use of thiazide and loop diuretics in patients with chronic kidney disease (CKD). This review summarizes recent studies impacting indications and safety considerations for these agents in patients with CKD.
A randomized trial of furosemide vs hydrochlorothiazide in patients with chronic renal failure and hypertension. [2013]Loop diuretics are the drugs of choice for the treatment of hypertension in chronic renal failure patients. However, the adaptive changes in the distal nephron and the short half-life of these drugs may decrease their long-term efficacy. Thiazides are not believed to be efficient in advanced renal failure, but this is debated.
The place of loop diuretics in the treatment of acute and chronic renal failure. [2010]Loop diuretics (furosemide, bumetanide, muzolimine, piretamide, torasemide) are powerful drugs capable of increasing sodium excretion and urine output even when renal function is markedly impaired. In patients with chronic renal failure (CRF), loop diuretics may be given to control extracellular volume (ECV) expansion responsible for hypertension. But the use of loop diuretics in chronic uremia is mostly helpful when impaired renal function co-exists with nephrotic syndrome or chronic heart failure. Due to their powerful natriuretic activity, loop diuretics have been administered also to patients on maintenance dialysis to reduce the frequency of and/or to curtail dialysis time. In this condition, however, the increase of sodium and water excretion is very limited; whereas the use of diuretics in high dosage is not devoid of risky side effects such as neurologic lesions, cramps, deafness, weakness, muscle pain. In some patients with oliguric form of acute renal failure (ARF), loop diuretics increase sodium excretion and urine output. They do not affect the mortality rate for ARF but may facilitate the treatment of patients by reverting an oliguric form to a non-oliguric form of ARF.
Clinical pharmacology of diuretics. [2019]Diuretics belong to the drugs most frequently used. Thiazide diuretics, loop diuretics and potassium sparing diuretics are the agents with practical significance. Many data concerning the pharmacokinetics of these drugs have been reported. Nevertheless, the metabolism of some diuretics is not yet fully elucidated. There are numerous pharmacodynamic drug interactions with diuretics which in general can be predicted from the spectrum of pharmacodynamic actions of the drugs involved.
Thiazide diuretic prescription and electrolyte abnormalities in primary care. [2022]Thiazide diuretics have a number of well-documented metabolic adverse effects. The aim of this study was to estimate the frequency of hyponatraemia and hypokalaemia amongst patients taking a thiazide diuretic in primary care.
Thiazides in chronic kidney disease: "back to the future". [2023]The thiazide class diuretics are first-line agents for managing hypertension either as monotherapy or as a fixed-dose combination with other antihypertensive drugs. However, despite the extensive experience with these drugs for >60 years, there is general reluctance to use these agents in patients with advanced chronic kidney disease (CKD) because of concerns about their efficacy and safety as kidney function declines. In this issue of Clinical Kidney Journal, Minutolo et al. performed an updated review of the pharmacological properties, efficacy and side effects and randomized controlled trials that tested these drugs in patients with CKD.
Comparison of Clinical Outcomes and Safety Associated With Chlorthalidone vs Hydrochlorothiazide in Older Adults With Varying Levels of Kidney Function. [2023]Thiazide diuretics are commonly prescribed for the treatment of hypertension, a disease highly prevalent among older individuals and in those with chronic kidney disease. How specific thiazide diuretics compare in regard to safety and clinical outcomes in these populations remains unknown.
[Potassium-sparing diuretics (spironolactone, triamterene, amylorid)]. [2013]The group of drugs, so-called "potassium sparing diuretics" represent an important part of our modern therapeutic arsenal. Their "weak diuretic" properties are especially beneficial in cirrhotic patients with ascites, when highly effective loop diuretics may be hazardous. Potassium sparing diuretics have not only the advantage of avoiding potassium loss, but can potentiate the effects of diuretics acting in distal tubules and Henle's loop also. They may be combined by each other or ACE inhibitors too, taking the necessary precautions and laboratory monitoring. Their indications include the hypertension and special diseases as Conn's, Bartter's, Liddle syndromes and hirsutism. The broad clinical usefulness justifies the drug inventory ambition to develop new, more effective potassium sparing compounds without side effects. Authors overview their main clinicofarmacological properties, therapeutical indications alone or in combinations and their potential side effects.
Effect of the combination of bumetanide plus chlorthalidone on hypertension and volume overload in patients with chronic kidney disease stage 4-5 KDIGO without renal replacement therapy: a double-blind randomized HEBE-CKD trial. [2022]The co-administration of loop diuretics with thiazide diuretics is a therapeutic strategy in patients with hypertension and volume overload. The aim of this study was to assess the efficacy and safety of treatment with bumetanide plus chlorthalidone in patients with chronic kidney disease (CKD) stage 4-5 KDIGO.