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.
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 10 August 2023
🗓️ Primary Completion (Estimated) June 2027
✅ Study Completion (Estimated) June 2027
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 New Haven, Connecticut, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Chronic clinical diagnosis of HF with a documented ejection fraction \<40%.
    • 2. Use of beta blocker, ACE, ARB or neprilysin inhibitor (sacubitril/valsartan), aldosterone antagonist, and SGLT2 inhibitor at ≥50% guideline directed doses for 30 days with no plan for titration/change during the study period.
    • 3. Chronic stable use of ≥80mg furosemide equivalents per day for ≥ 30 days
    • 4. Peak FENa \< 5% following 10mg IV bumetanide challenge at the screening visit
    • 5. Absence of hospitalizations in the previous 3 months.
    • 6. At optimal volume status by symptoms, exam, and dry weight.
    • 7. Serum potassium ≤ 5.0 mmol/L
    • 8. Serum sodium ≥ 130 mEq/L
    • 9. Age \> 18 years

    Exclusion Criteria:

    • 1. GFR \<20 ml/min/1.73m2
    • 2. Use of any non-loop type diuretic in the last 14 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg)
    • 3. History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy
    • 4. Hemoglobin \< 8 g/dL
    • 5. Pregnant or breastfeeding
    • 6. Inability to give written informed consent or comply with study protocol or follow-up visits
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 February 2023
  • First Submitted that Met QC Criteria 21 February 2023
  • First Posted 3 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 June 2024
  • Last Update Posted 4 June 2024
  • Last Verified June 2024