Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction
Condition: Heart Failure, Diastolic
MeSH terms: Heart Failure; Heart Failure, Diastolic
Intervention: Furosemide; Dopamine
Intervention MeSH terms: Dopamine; Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure, diastolic; HFpEF; Diuretics; Dopamine

Summary:

      Heart Failure with preserved Ejection Fraction (HFPEF) accounts for 40-50% of all heart
      failure patients with a frequency of hospital admissions for acute decompensation and short
      and long term mortality similar to patients with heart failure with reduced ejection fraction
      (HFREF). Patients with HFPEF are often preload dependent and despite admission to the
      hospital for acute decompensated heart failure (ADHF), are typically difficult to diurese due
      to the development of acute kidney injury. No studies have been performed evaluating
      treatment strategies for these patients. The investigators hypothesize that changing the
      method of diuresis and/or the addition of low-dose dopamine for the treatment of ADHF in
      patients with HFPEF will reduce renal injury, resulting in a shorter length of stay, and
      decrease hospital readmissions over the ensuing year. This trial will randomize patients to
      either bolus or continuous infusion furosemide and then to either dopamine or no dopamine.
      The primary endpoint will be renal function at 72 hours as measured by change in Glomerular
      Filtration Rate (GFR). Secondary endpoints for readmission, functional capacity, quality of
      life, and amount of diuresis will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admission to Johns Hopkins Hospital for acute decompensated heart failure.

          -  Patient ≥18 years of age

          -  Estimated GFR of > 15 milliliters/min/1.73m2 determined by the Modification of Diet in
             Renal Disease (MDRD) equation

          -  Willingness to provide informed consent

          -  Known ejection fraction by noninvasive testing of > 50% within 12 months of admission
             to the hospital with no interval myocardial infarction since inclusion transthoracic
             echo, by history, or by ECG.

          -  Negative pregnancy test in a female of child bearing potential

          -  Willingness of primary attending physician for patient to participate.

        Exclusion Criteria:

          -  Systolic BP <90 mmHg on admission

          -  Hemoglobin (Hgb) < 8 g/dl

          -  Known allergy or intolerance to furosemide or low dose dopamine.

          -  Hemodynamically significant arrhythmias including ventricular tachycardia or
             defibrillator shock within 4 weeks

          -  Acute coronary syndrome within 4 weeks

          -  Cardiac diagnoses in addition to or other than HFpEF:

             i. Active myocarditis ii. Hypertrophic obstructive cardiomyopathy iii. Severe valvular
             disease iv. Restrictive or constrictive cardiomyopathy, including known amyloidosis,
             sarcoidosis, hemachromatosis v. Complex congenital heart disease vi. Constrictive
             pericarditis vii. Severe pulmonary hypertension (RVSP ≥ 60), not secondary to HFpEF

          -  Non-cardiac pulmonary edema

          -  Clinical evidence of digoxin toxicity

          -  Received IV vasoactive treatment or ultra-filtration therapy for heart failure since
             initial presentation

          -  Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure
             during this hospitalization

          -  History of temporary or permanent renal replacement therapy or ultrafiltration

          -  History of renal artery stenosis > 50%

          -  Need for mechanical hemodynamic support

          -  Sepsis

          -  Terminal illness (other than HF) with expected survival of less than 1 year

          -  Previous adverse reaction to the study drugs

          -  Use of IV iodinated contrast material/dye in last 72 hours or planned during
             hospitalization

          -  Enrollment or planned enrollment in another randomized clinical trial during this
             hospitalization

          -  Inability to comply with planned study procedures

          -  Pregnancy or nursing mothers