Status:
TERMINATED
Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
University of Illinois at Chicago
Virginia Commonwealth University
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Patients hospitalized for ADHF secondary to fluid overload and who are experiencing an inadequate response to IVB furosemide and require additional diuresis will be enrolled. Patients will be randomiz...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00904488
Start Date
October 1 2008
End Date
November 14 2017
Last Update
March 13 2018
Active Locations (1)
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1
UNC_Chapel Hill
Chapel Hill, North Carolina, United States, 27599