Testing Two Water Pills With Bumetanide in Heart Failure
Tests water pills added to bumetanide in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Mechanisms of Diuretic Resistance in Heart Failure, Aim 2
Key facts
- Where
- New Haven, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Yale UniversityNew Haven, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yale University
- Trial code
- NCT05753059
- Record updated
- 8 September 2026
- Original description
Randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.Read full original descriptionShow less
Mechanisms of Diuretic Resistance in Heart Failure, Aim 2
Randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.
Inclusion: Clinical diagnosis of HF; No plan for titration/change of heart failure medical or device therapies during the study period; Absence of non-elective hospitalizations in the previous 2 weeks; At optimal volume status by symptoms, exam, and dry weight; Serum potassium ≤ 5.0 mmol/L; Serum sodium ≥ 130 mEq/L; Age > 18 years; Hemoglobin ≥8 g/dL; Objective evidence of diuretic resistance to a 10mg bumetanide challenge, defined as:; FENa <10% and total sodium output <150mmol and; At least one of the following criteria:; Chronic home furosemide dose > or equal to 80mg furosemide equivalents daily 2. eGFR < 60ml/min 3. Serum chloride <100mmol/L 4. FENa <5% and total sodium output <75mmol on the 2 hour screening.
Exclusion: History of flash pulmonary edema requiring hospitalization and treatment with biphasic positive airway pressure or mechanical ventilation or a "brittle" volume sensitive HF phenotype such as an infiltrative or restrictive cardiomyopathy (i.e. amyloid cardiomyopathy, etc); On Lithium therapy; Diagnosis of liver failure; Contraindications or allergy to sulfonamides; Any contraindication to thiazide diuretic or allergy to thiazide or bendroflumethiazide; GFR <20 ml/min/1.73m2 using the CKD-EPI equation or use of renal replacement therapies; Hemoglobin < 8 g/dL or symptomatic anemia; Use of any non-loop type diuretic in the last 7 days or 5 half lives, with the exclusion of low dose aldosterone antagonist (e.g., spironolactone or eplerenone ≤50 mg). Examples of non-loop diuretics include but may not be limited to acetazolamide (oral or IV, not ophthalmic), metolazone, HCTZ, chlorthalidone, chlorothiazide, indapamide, triamterene, amiloride, finerenone, spironolactone dose > 50mg day, eplerenone > 50mg/day,; Pregnant or breastfeeding; Inability to give written informed consent or comply with study protocol or follow-up visits; Chronic urinary retention limiting ability to perform timed urine collection procedures; On pimozide or thioridazine.