EdemaNCT04759274
Diuretic Tuner Clinical Decision Support
A study testing Diuretic Tuner in people with Edema and Hypervolemia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edema, Hypervolemia, Chronic Kidney Diseases
- What is being tested?
- Diuretic Tuner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Weight < 100 lbs or > 300 lbs.
- Autonomic insufficiency resulting in orthostatic hypotension at screening
- 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
- Patients who are unable or unwilling to measure their home blood pressures and weights
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- 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
- The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)
- Pregnant patients
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Kamalanathan K Sambandam, 469-441-7181, ksambandam@utsouthwestern.edu
About this study
Official title: Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States
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.
Read the detailed description
Study Population: 30 subjects with signs of hypervolemia and either nephrotic syndrome or chronic kidney disease 4 to 5.
Study Intervention: This is a nonrandomized, uncontrolled trial. The Diuretic Tuner mobile device application will be deployed in the care of hypervolemic subjects as defined in the study population. The Diuretic Tuner will integrate each subject's estimated dry weight and starting diuretic dose (both defined by healthcare provider) with daily weights and blood pressures to provide individualized guidance to the subject in day-to-day adjustments to his or her diuretic regimen. In addition, the application will generate a diary of daily weights, blood pressures, fluid intake, and medication compliance. There will be no control arm as this first phase is to test feasibility/safety.
Study Outcome Measures: The primary outcomes of interest will focus on the achievement of the provider-defined estimated dry weight (both the time to achieving this target as well as the subsequent stability in weights around this target). Secondary outcomes of interest include safety metrics (3-month hospitalization rates, rates of hypokalemia, and rates of acute kidney injury) and tool usability (assessed through surveys evaluating ease of comprehension and satisfaction).
- Conditions
- Edema, Hypervolemia, Chronic Kidney Diseases, Nephrotic Syndrome
- Being tested
- Diuretic Tuner
- Medical subject headings
- Edema, Renal Insufficiency, Chronic, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diuretic TunerDevice
Mobile device application for diuretic dose titration
| Study group | Role | What they receive |
|---|---|---|
| Diuretic Tuner users | Experimental | 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. Receives: Device: Diuretic Tuner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to the attainment of dry weight
Mean time in days to the attainment of the provider-specified estimated dry weight
Measured: 90 days
90 day weight variability
90 day weight variability around the target dry weight, as assessed by standard deviation
Measured: 90 days
Secondary outcomes (2)
Composite rate of hospitalization, hypokalemia, or acute renal insufficiency
90 day adverse event rate for the composite outcome including hospitalization for volume-related complications (hypervolemia, hypovolemia, or electrolyte disturbance), hypokalemia (serum potassium < 3.5 mmol/L), or acute renal insufficiency (serum creatinine ≥ 2 times baseline or > 6 mg/dL)
Measured: 90 days
Diuretic Tuner usability assessed by user survey
Diuretic tuner usability (measured by Likert scale survey administered to each subject at the end of 90 days)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start20 Nov 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamalanathan Sambandam, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759274
- Sponsor's protocol ID
- STU 2020-1124
- Status last verified
- Sep 2025
- First submitted
- 9 Feb 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States
- ClinicalTrials.gov ID
- NCT04759274
- Acronym / sponsor ID
- STU 2020-1124
- Conditions
- Edema, Hypervolemia, Chronic Kidney Diseases, Nephrotic Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Population: 30 subjects with signs of hypervolemia and either nephrotic syndrome or chronic kidney disease 4 to 5.
Study Intervention: This is a nonrandomized, uncontrolled trial. The Diuretic Tuner mobile device application will be deployed in the care of hypervolemic subjects as defined in the study population. The Diuretic Tuner will integrate each subject's estimated dry weight and starting diuretic dose (both defined by healthcare provider) with daily weights and blood pressures to provide individualized guidance to the subject in day-to-day adjustments to his or her diuretic regimen. In addition, the application will generate a diary of daily weights, blood pressures, fluid intake, and medication compliance. There will be no control arm as this first phase is to test feasibility/safety.
Study Outcome Measures: The primary outcomes of interest will focus on the achievement of the provider-defined estimated dry weight (both the time to achieving this target as well as the subsequent stability in weights around this target). Secondary outcomes of interest include safety metrics (3-month hospitalization rates, rates of hypokalemia, and rates of acute kidney injury) and tool usability (assessed through surveys evaluating ease of comprehension and satisfaction).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diuretic Tuner users | Experimental | Device: Diuretic TunerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- Weight < 100 lbs or > 300 lbs.
- Autonomic insufficiency resulting in orthostatic hypotension at screening
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diuretic TunerMobile device application for diuretic dose titration | Device | Diuretic Tuner users |
Primary outcome
Mean time to the attainment of dry weight
Time frame: 90 days
Mean time in days to the attainment of the provider-specified estimated dry weight
90 day weight variability
Time frame: 90 days
90 day weight variability around the target dry weight, as assessed by standard deviation
2 secondary outcomes
Composite rate of hospitalization, hypokalemia, or acute renal insufficiency
Time frame: 90 days
Diuretic Tuner usability assessed by user survey
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diuretic Tuner in people with Edema and Hypervolemia, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamalanathan K Sambandam, M.D. (214-645-6190, ksambandam@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time to the attainment of dry weight (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.