Heart Failure Clinical Trial
— MsDR Aim 3Official title:
Mechanisms of Diuretic Resistance in Heart Failure, Aim 3
Verified date | June 2024 |
Source | Yale University |
Contact | Veena Rao, PHD |
Phone | 2037373571 |
veena.s.rao[@]yale.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Randomized double-blind placebo-controlled crossover study design
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | March 1, 2028 |
Est. primary completion date | March 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Clinical diagnosis of heart failure - No plan for titration/change of heart failure medical or device therapies during the study period. - Peak fractional excretion of sodium (FENa) < 5% following 10mg IV bumetanide challenge at the screening visit - Absence of non-elective hospitalizations in the previous 2 months. - At optimal volume status by symptoms, exam, and dry weight. - Serum potassium = 5.0 mmol/L - Serum sodium = 130 milliequivalents/ liter (mEq/L) - Hemoglobin =8 g/dL Exclusion Criteria: - 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 - Pregnant or breastfeeding - Cirrhosis or known liver disease - History of metabolic or respiratory acidosis within 30 days - Use of metformin, acetazolamide, or any other agent that could predispose to acidosis - Patients who are on metformin may be enrolled if their metformin can be safely discontinued for the randomized treatment periods in each arm. Any participants who have consistently elevated blood glucose readings > 200 mg/dL while inpatient will not be enrolled. - Serum bicarbonate level <24mmol/L at screening visit - Venous potential of hydrogen(pH) <7.35 at screening visit - Inability to give written informed consent or comply with study protocol or follow-up visits - On Lithium therapy - On pimozide or thioridazine - Diagnosis of liver failure - Contraindications or allergy to sulfonamides - Any contraindication to thiazide diuretic or allergy to thiazide or bendroflumethiazide |
Country | Name | City | State |
---|---|---|---|
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 0 vs Day 1 | |
Primary | Change in urinary extracellular vesicles (uEV) pendrin/exosomal marker(CD9) with the change in distal sodium reabsorption(ADRNa), compared between the placebo and NH4Cl | Change in uEV pendrin/CD9 with the change in ADRNa, compared between the placebo and NH4Cl study visits | Day 2 vs Day 18 | |
Primary | 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. | Day 2 vs Day 18 |
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