Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study
Condition: Acute Heart Failure
MeSH terms: Dyspnea; Heart Failure
Intervention: Placebo; Nesiritide; Dopamine
Intervention description: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.; Active Comparator: Low Dose Nesiritide
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.; Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
Intervention MeSH terms: Dopamine; Natriuretic Peptide, Brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the benefits and safety of intravenous
      administration of low dose nesiritide or low dose dopamine in patients with congestive heart
      failure and kidney dysfunction. There is a substudy in a subset of subjects that is being
      used to determine whether the Provocative Dyspnea Severity Score (pDSS) is a more sensitive
      index of variability in clinical status than the dyspnea VAS assessed without standardization
      of conditions at assessments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A 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)

          -  Prior clinical diagnosis of heart failure Must be identified within 24 hours of
             hospital admission (24 hour clock begins when the admission orders are placed)

          -  Estimated GFR of > 15 but < 60 mL/min/1.73m2 determined by the MDRD equation

          -  Male or female patient ≥18 years old

          -  Willingness to provide informed consent

          -  Ability to have a PICC or central line placed (if needed) within 12 hours of
             randomization and study drug infusion started

          -  Anticipated hospitalization of at least 72 hours

        Exclusion Criteria:

          -  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

          -  Systolic BP <90 mmHg

          -  Hemoglobin (Hgb) < 9 g/dl

          -  Renal replacement therapy

          -  History of renal artery stenosis > 50%

          -  Hemodynamically significant arrhythmias including ventricular tachycardia or
             defibrillator shock within 4 weeks

          -  Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG)
             ST-segment depression or prominent T-wave inversion and/or positive biomarkers of
             necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate
             clinical setting (chest discomfort or anginal equivalent)

          -  Active myocarditis

          -  Hypertrophic obstructive cardiomyopathy

          -  Greater than moderate 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 HF) with expected survival of less than 1 year

          -  Previous adverse reaction to the study drugs

          -  Use of IV iodinated radiocontrast material 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