Mechanisms of Diuretic Resistance in Heart Failure, Aim 2
Yale University
Summary
Randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.
Description
This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide. Patients will be co-enrolled in this study and an ancillary study for administration of Bendroflumethiazide. Administration of bendroflumethiazide will take place under an ancillary protocol.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Clinical diagnosis of HF 2. No plan for titration/change of heart failure medical or device therapies during the study period. 3. Absence of non-elective hospitalizations in the previous 2 weeks 4. At optimal volume status by symptoms, exam, and dry weight. 5. Serum potassium ≤ 5.0 mmol/L 6. Serum sodium ≥ 130 mEq/L 7. Age \> 18 years 8. Hemoglobin ≥8 g/dL 9. Objective evidence of diuretic resistance to a 10mg bumetanide challenge, defined as: 1. FENa \<10% and total sodium output \<150mmol and 2. At least one of the following criteria: 1\. Chronic home furosemi…
Interventions
- DrugPlacebo
This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, added to bumetanide on Days 0, 7, 14 and 21
- DrugAmiloride
This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations of amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide on Days 0, 7, 14 and 21
- DrugBendroflumethiazide
This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations of bendroflumethiazide/placebo and bendroflumethiazide/amiloride added to bumetanide on Days 0, 7, 14 and 21
Location
- Yale UniversityNew Haven, Connecticut