Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure

Stopped early · Phase 4

Conditions studied: Acute Decompensated Heart Failure

In brief

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.

Key facts

Study ID

NCT00904488

Run by

University of North Carolina, Chapel Hill

People needed

11

Starts

2008-10-01

Expected to finish

2017-11-14

Last updated by the study team

2018-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Greater than or equal to 18 years of age
• 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)
• Inadequate response to IV diuretics and requiring additional diuresis as determined by primary medical team
• Received less than six doses of IV furosemide OR enrolled within 72 hours of hospital admission
• Anticipated need for intravenous diuretic therapy for at least 48 hours
• Able to provide informed consent

You may not qualify if…

• Receiving a continuous infusion loop diuretic during current hospital visit
• 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)
• 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
• 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
• Systolic blood pressure < 90 mmHg
• Serum creatinine > 3 mg/dL at baseline or renal replacement therapy including ultrafiltration
• Serum potassium < 3.5 mEq/L (3.0 - 3.4 mEq/L allowed if supplemental potassium is being administered)
• Serum magnesium < 1.6 mg/dL (1.4 - 1.5 mg/dL allowed if supplemental magnesium is being administered)
• Acute coronary syndrome or hemodynamically significant arrhythmias causing worsening HF
• Severe, uncorrected primary cardiac valvular disease, acute myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, complex congenital heart disease
• Primary pulmonary hypertension with right sided heart failure
• Use of iodinated radiocontrast material in prior 72 hours or planned within the next 48 hours
• Enrollment or planned enrollment in another randomized clinical trial during hospitalization

Where it is running

• UNC_Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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