Mechanisms of Diuretic Resistance in Heart Failure, Aim 3
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
Randomized double-blind placebo-controlled crossover study design
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of heart failure
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 months.
At optimal volume status by symptoms, exam, and dry weight.
Disqualifiers
Glomerular filtration rate (GFR) <20 ml/min/1.73m2
Use of any non-loop type diuretic in the last 7 days with the exclusion of low dose aldosterone antagonist (e.g., spironolactone ≤50 mg)
History of flash pulmonary edema or a "brittle" volume sensitive HF phenotype such as amyloid cardiomyopathy
Hemoglobin < 8 g/dL
Trial design
Design model
Crossover
Treatments tested in this trial
Ammonium Chloride
DrugParticipants will be randomized to receive either ammonium chloride or placebo. Participants will receive randomized drug in combination with IV bumetanide, bendroflumethiazide, and amiloride. Following a washout period, participants will be crossed over to the alternate drug.
Placebo
DrugParticipants will be randomized to receive either ammonium chloride or placebo. Participants will receive randomized drug in combination with IV bumetanide, bendroflumethiazide, and amiloride. Following a washout period, participants will be crossed over to the alternate drug.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Ammonium chlorideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of distal sodium reabsorption(ADRNa) between NH4Cl vs. placebo study visits
Comparison of ADRNa between NH4Cl vs. placebo during study visits using fractional excretion of lithium and fractional excretion of sodium to calculate the ADRNa.
Time frame
Day 0 vs Day 12
Change of distal sodium reabsorption(ADRNa) between NH4Cl vs. placebo study visits
Comparison of ADRNa between NH4Cl vs. placebo during study visits using fractional excretion of lithium and fractional excretion of sodium to calculate the ADRNa.
Time frame
Day 2 vs Day 18Sponsors and contacts
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Yale University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov