Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Dopamine; Dopamine Agents; Natriuretic Peptide, Brain

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