30 Participants Needed

Diuretic Tuner App for Chronic Kidney Disease

KK
Overseen ByKamalanathan K Sambandam, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
Must be taking: Diuretics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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.12345

Is 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.36789

How 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.3481011

Eligibility 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)
See 9 more

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

Treatment Details

Interventions

  • Diuretic Tuner
Trial Overview 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.
Participant Groups
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:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Diuretics for:
  • High Blood Pressure
  • Edema
  • Heart Failure
  • Chronic Kidney Disease
  • Liver Disease
πŸ‡ΊπŸ‡Έ
Approved in United States as Diuretics for:
  • High Blood Pressure
  • Edema
  • Heart Failure
  • Chronic Kidney Disease
  • Liver Disease
πŸ‡¨πŸ‡¦
Approved in Canada as Diuretics for:
  • High Blood Pressure
  • Edema
  • Heart Failure
  • Chronic Kidney Disease
  • Liver Disease
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Approved in Japan as Diuretics for:
  • High Blood Pressure
  • Edema
  • Heart Failure
  • Chronic Kidney Disease
  • Liver Disease
πŸ‡¨πŸ‡³
Approved in China as Diuretics for:
  • High Blood Pressure
  • Edema
  • Heart Failure
  • Chronic Kidney Disease
  • Liver Disease
πŸ‡¨πŸ‡­
Approved in Switzerland as Diuretics for:
  • High Blood Pressure
  • Edema
  • Heart Failure
  • Chronic Kidney Disease
  • Liver Disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Findings from Research

In a study of 33 patients with severe congestive cardiac failure, a fixed 3-day course of a combination of thiazide and loop diuretics was found to be as effective as longer treatment durations in managing the condition.
Both thiazide diuretics, bendrofluazide and metolazone, were equally effective in promoting weight loss due to fluid removal, but bendrofluazide resulted in fewer electrolyte disturbances, suggesting it may be a safer option.
Combination diuretic treatment in severe heart failure: a randomised controlled trial.Channer, KS., McLean, KA., Lawson-Matthew, P., et al.[2019]
Diuretics have transformed the treatment of various conditions, turning once fatal diseases into manageable ones, particularly in cases of salt and water overload and edema.
Different types of diuretics are used for specific conditions: thiazide diuretics for hypertension, loop diuretics for edema and heart failure, and potassium-sparing diuretics for preventing low potassium levels, highlighting their versatility and importance in modern medicine.
Edema and principles of diuretic use.Morrison, RT.[2019]
Chlorthalidone has been shown to effectively reduce blood pressure in patients with advanced chronic kidney disease (CKD), suggesting that thiazide diuretics can still be beneficial even at lower glomerular filtration rates (GFR).
While diuretics can have adverse effects, recent studies indicate that they do not negatively impact kidney or cardiovascular outcomes in CKD patients, and careful monitoring of electrolytes and GFR is essential for safe use.
Revisiting diuretic choice in chronic kidney disease.Ali, S., Navaneethan, SD., Virani, SS., et al.[2023]

References

Combination diuretic treatment in severe heart failure: a randomised controlled trial. [2019]
Edema and principles of diuretic use. [2019]
Revisiting diuretic choice in chronic kidney disease. [2023]
A randomized trial of furosemide vs hydrochlorothiazide in patients with chronic renal failure and hypertension. [2013]
The place of loop diuretics in the treatment of acute and chronic renal failure. [2010]
Clinical pharmacology of diuretics. [2019]
Thiazide diuretic prescription and electrolyte abnormalities in primary care. [2022]
Thiazides in chronic kidney disease: "back to the future". [2023]
Comparison of Clinical Outcomes and Safety Associated With Chlorthalidone vs Hydrochlorothiazide in Older Adults With Varying Levels of Kidney Function. [2023]
[Potassium-sparing diuretics (spironolactone, triamterene, amylorid)]. [2013]
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]
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