Actively Recruiting
Mechanisms of Diuretic Resistance in Heart Failure, Aim 3
Led by Yale University · Updated on 2024-10-08
50
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Randomized double-blind placebo-controlled crossover study design
CONDITIONS
Official Title
Mechanisms of Diuretic Resistance in Heart Failure, Aim 3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of heart failure
- No planned changes in heart failure medications or devices during the study period
- No non-elective hospitalizations in the previous 2 months
- At optimal volume status by symptoms, exam, and dry weight
- Serum potassium less than or equal to 5.0 mmol/L
- Serum sodium greater than or equal to 130 mEq/L
- Hemoglobin 8 g/dL or higher
- Age over 18 years
- Objective evidence of diuretic resistance to 10 mg bumetanide challenge defined as FENa less than 10% and total sodium output less than 150 mmol
- And at least one of the following: chronic home furosemide dose 80 mg or more, eGFR less than 60 ml/min, serum chloride less than 100 mmol/L, or FENa less than 5% and total sodium output less than 75 mmol on the 2-hour test
You will not qualify if you...
- Glomerular filtration rate (GFR) less than 20 ml/min/1.73m2
- Use of any non-loop diuretic in last 7 days except low dose aldosterone antagonist (e.g., spironolactone 50 mg or less)
- History of flash pulmonary edema or brittle volume sensitive heart failure such as amyloid cardiomyopathy
- Hemoglobin less than 8 g/dL
- Pregnant or breastfeeding
- Cirrhosis or known liver disease
- History of metabolic or respiratory acidosis within 30 days
- Use of metformin, acetazolamide, or other agents that may cause acidosis unless metformin can be safely stopped during treatment periods
- Consistently elevated blood glucose above 200 mg/dL during inpatient stay
- Serum bicarbonate less than 24 mmol/L at screening
- Venous pH less than 7.35 at screening
- Inability to give written informed consent or comply with study procedures
- Current lithium therapy
- Use of pimozide or thioridazine
- Diagnosis of liver failure
- Allergy or contraindication to sulfonamides
- Allergy or contraindication to thiazide diuretics or bendroflumethiazide
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
Research Team
V
Veena Rao, PHD
CONTACT
K
Kara Otis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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