Edema study: Diuretic Tuner
Official title Diuretic Tuner Clinical Decision Support
ClinicalTrials.gov ID: NCT04759274
What this study is testing
- What it's testing
- This study checks if a mobile app can help doctors and patients better control body swelling caused by kidney issues.
- Who it's for
- People with kidney problems who have swelling or too much fluid in their bodies.
- What's involved
- You will use a phone app to track your weight and blood pressure daily and follow its instructions for taking your water pills. You will also have blood tests at specific times during the study.
- Time commitment
- The study lasts 90 days and includes a 2-hour start visit, daily app use, periodic blood tests, and a final 2-hour visit.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The presence of nephrotic range proteinuria (\> 3 g/d proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein/creatinine ratio, or...
- Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free...
You likely can't join if
- Weight \ 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
See the full eligibility criteria
- 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...
- 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 \ 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.