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NCT05753059
Mechanisms of Diuretic Resistance in Heart Failure, Aim 2
Conditions: Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 50
Sponsor: Yale University
Location: Yale University New Haven Connecticut
Summary
Randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT05753059). StuddyBuddy aggregates publicly available trial information.