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

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University of Virginia

Status and phase

Terminated
Phase 4

Conditions

Cardiovascular Diseases
Heart Failure With Reduced Ejection Fraction
Heart Failure
Heart Failure Acute

Treatments

Drug: Metolazone Oral Tablet
Drug: Chlorothiazide Injection

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

Metolazone
Active Comparator group
Description:
Metolazone 5 mg by mouth once daily for 2 days
Treatment:
Drug: Metolazone Oral Tablet
Chlorothiazide
Active Comparator group
Description:
Chlorothiazide 500 mg IV once daily for 2 days
Treatment:
Drug: Chlorothiazide Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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