Comparison of Oral or Intravenous Thiazides vs Tolvaptan in Diuretic Resistant Decompensated Heart Failure
Completed
Vanderbilt University
Phase 4
2016-02-01
Broad Objectives: To determine the comparative efficacy of commonly employed strategies to
overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized
decompensated heart failure patients with hypervolemia
Specific Aims:
1. Compare the 48-hour weight change of either intravenous chlorothiazide or oral tolvaptan
compared to standard-of-care oral metolazone when combined with standardized loop
diuretic dosing for diuretic resistance in decompensated heart failure
2. Compare the adverse effects of electrolyte depletion and renal function changes between
intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral
metolazone when combined with standardized loop diuretic dosing for diuretic resistance
in acute heart failure
3. Pharmacoeconomic analysis of the direct costs of intravenous chlorothiazide or oral
tolvaptan compared to standard-of-care oral metolazone when combined with standardized
loop diuretic dosing for diuretic resistance in acute heart failure
The investigators will conduct a dual center, randomized, double-blind, double-dummy,
parallel design trial comparing: oral metolazone, intravenous chlorothiazide, or oral
tolvaptan, in combination with loop diuretics in 60 patients hospitalized for hypervolemic
decompensated heart failure and displaying loop diuretic resistance.
Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
Terminated
University of Virginia
Phase 4
2018-06-01
The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as
add-on therapy in patients refractory to loop diuretics with heart failure with a reduced
ejection fraction (HFrEF). This will be a single-center randomized pilot study.
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