Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Intervention: Addition of oral Metolazone; Furosemide dose escalation
Intervention description: Addition of oral metolazone 5 mg daily to continued current dose of intravenous bolus furosemide; Furosemide dose escalation via either IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours)
Intervention MeSH terms: Metolazone; Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Decompensated Heart Failure; Diuretics

Summary:

      The purpose of this prospective, randomized, open-label study is to compare two diuretic
      strategies in patients with acute decompensated heart failure (ADHF): the addition of an oral
      thiazide diuretic to intravenous bolus (IVB) loop diuretic will be compared to transition
      from IVB to continuous infusion (CI) loop diuretic.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Greater than or equal to 18 years of age

          2. Hospitalized for acute decompensated heart failure (ADHF) secondary to fluid overload
             as defined by the presence of at least

               -  1 symptom (e.g. dyspnea, orthopnea, paroxysmal nocturnal dyspnea) AND

               -  1 sign (e.g. rales on auscultation, > 2+ peripheral or presacral> edema,
                  hepatomegaly, ascites, jugular vein distension > 7 cm, pulmonary vascular
                  congestion on chest radiography)

          3. Inadequate response to IV diuretics and requiring additional diuresis as determined by
             primary medical team

          4. Received less than six doses of IV furosemide OR enrolled within 72 hours of hospital
             admission

          5. Anticipated need for intravenous diuretic therapy for at least 48 hours

          6. Able to provide informed consent

        Exclusion Criteria:

          1. Receiving a continuous infusion loop diuretic during current hospital visit

          2. Substantial diuretic response to pre-randomization diuretic dosing such that higher
             doses of diuretic would be contraindicated (based on judgement of patient's primary
             team)

          3. Planned or ongoing intravenous vasoactive therapy (e.g. inotrope, vasodilator) or
             mechanical support (e.g. intra-aortic balloon pump, ventricular assist device) for
             ADHF during this hospitalization

          4. Planned elective admission for elective placement/revision of a cardiovascular device
             (e.g. defibrillator, biventricular pacemaker) during this hospitalization or such
             within the preceding 7 days

          5. Systolic blood pressure < 90 mmHg

          6. Serum creatinine > 3 mg/dL at baseline or renal replacement therapy including
             ultrafiltration

          7. Serum potassium < 3.5 mEq/L (3.0 - 3.4 mEq/L allowed if supplemental potassium is
             being administered)

          8. Serum magnesium < 1.6 mg/dL (1.4 - 1.5 mg/dL allowed if supplemental magnesium is
             being administered)

          9. Acute coronary syndrome or hemodynamically significant arrhythmias causing worsening
             HF

         10. Severe, uncorrected primary cardiac valvular disease, acute myocarditis, constrictive
             pericarditis, hypertrophic obstructive cardiomyopathy, restrictive or constrictive
             cardiomyopathy, complex congenital heart disease

         11. Primary pulmonary hypertension with right sided heart failure

         12. Use of iodinated radiocontrast material in prior 72 hours or planned within the next
             48 hours

         13. Enrollment or planned enrollment in another randomized clinical trial during
             hospitalization