Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance

• Status: Terminated
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Chlorothiazide; Diuretics; Metolazone

Criteria

Inclusion Criteria:

• Age > 18 years old

• Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) <40%

• Refractory fluid overload:

• Unresponsive (<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)

• English or Spanish-speaking subjects

• Willing and able to comply with study procedures

Exclusion Criteria:

• Baseline thiazide use prior to admission or prior to study enrollment

• Renal replacement therapies (RRT) or glomerular filtration rate (GFR) <30 mL/min at the time of enrollment

• Pregnant women

• Cognitive impairment

• Prisoners

• Left ventricular assist devices (LVAD) or temporary mechanical circulatory support devices

• History of cardiac transplant

• Reported allergy to thiazides

• No enteral access or unable to take medications enterally

• Palliative diuretics

• Systolic blood pressure (SBP) <90 mm Hg prior to randomization

• Patients receiving concomitant lithium therapy