NCT04759274Recruiting
Diuretic Tuner Clinical Decision Support
Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Feb 2021
- Start date
- Nov 2023
- Primary completion date
- Aug 2028
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT04759274
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Nov 2023 to the primary completion date, Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Autonomic insufficiency resulting in orthostatic hypotension at screening
- The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)
Lab values
- Hypokalemia at enrollment (defined as serum potassium \< 3.5 mmol/L)
- Moderate to severe hyponatremia at enrollment (defined as serum sodium \< 130 mmol/L)
- Serum creatinine \> 6 mg/dL or \> 1.5 times baseline
Other
- Weight \< 100 lbs or \> 300 lbs.
- Patients who are unable or unwilling to measure their home blood pressures and weights
- Patients without a working phone number and smart phone device
- Expectation that the patient will require dialysis initiation within \< 3 months
- Expected lifespan of \< 6 months
- Pregnant patients
- Prisoners
Who the study is looking for
- The presence of nephrotic range proteinuria (\> 3 g/d proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein/creatinine ratio, or spot urine albumin/creatinine ratio) or stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate \< 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease equation) PLUS
- Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free weight without orthostatic hypotension) 5 lbs less than enrollment body weight
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.