Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Furosemide-Q12 hour bolus; Furosemide-Continuous Infusion; Furosemide-Low Intensification; Furosemide-High Intensification
Intervention description: Q12 hours bolus; Continuous infusion; 1x oral dose; 2.5x oral dose
Intervention MeSH terms: Furosemide; Diuretics; Sodium Potassium Chloride Symporter Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 308.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Loop Diuretics; Furosemide; Fluid Overload; Cardio Renal Failure

Summary:

      Heart failure is a disorder in which the heart does not pump blood adequately. This can lead
      to several serious problems, including reduced blood flow throughout the body, congestion of
      blood in the veins and lungs, and fluid accumulation in various organs and limbs. Diuretics
      are often used to address the problem of fluid accumulation, but the optimal dose and the
      amount of time over which to administer each dose are unclear. This study will compare high
      and low doses of diuretics administered over longer and shorter periods of time to determine
      the safest and most effective combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior clinical diagnosis of heart failure that was treated with daily oral loop
             diuretics for at least 1 month

          -  Current diagnosis of heart failure, as defined by the presence of at least 1 symptom
             (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema,
             ascites, pulmonary vascular congestion on chest radiography)

          -  Daily oral dose of furosemide between 80 mg and 240 mg (or equivalent)

          -  Identified within 24 hours of hospital admission

          -  Current treatment plan includes IV loop diuretics for at least 48 hours

        Exclusion Criteria:

          -  Brain natriuretic peptide (BNP) less than 250 mg/mL or N-terminal prohormone brain
             natriuretic peptide (NT-proBNP) less than 1000 mg/mL

          -  Received IV vasoactive treatment or ultra-filtration therapy for heart failure since
             initial presentation

          -  Treatment plan during current hospitalization includes IV vasoactive treatment or
             ultra-filtration for heart failure

          -  Substantial diuretic response to pre-randomization diuretic dosing such that higher
             doses of diuretics would be medically inadvisable

          -  Systolic blood pressure less than 90 mm Hg

          -  Serum creatinine level greater than 3.0 mg/dL at baseline or currently undergoing
             renal replacement therapy

          -  Hemodynamically significant arrhythmias

          -  Acute coronary syndrome within 4 weeks prior to study entry

          -  Active myocarditis

          -  Hypertrophic obstructive cardiomyopathy

          -  Severe stenotic valvular disease

          -  Restrictive or constrictive cardiomyopathy

          -  Complex congenital heart disease

          -  Constrictive pericarditis

          -  Non-cardiac pulmonary edema

          -  Clinical evidence of digoxin toxicity

          -  Need for mechanical hemodynamic support

          -  Sepsis

          -  Terminal illness (other than heart failure) with expected survival time of less than 1
             year

          -  History of adverse reaction to the study drugs

          -  Use of IV iodinated radiocontrast material within 72 hours prior to study entry or
             planned during hospitalization

          -  Enrollment or planned enrollment in another randomized clinical trial during this
             hospitalization

          -  Inability to comply with planned study procedures