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Phase 2 N=360 Randomized Quadruple-blind Treatment

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

Acute Heart Failure

Enrolled (actual)
360
Serious AEs
20.8%
Results posted
Aug 2014
Primary outcome: Primary: Change in Cystatin C — .12; .11; .07 mg/L

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Placebo (Other); Nesiritide (Drug); Dopamine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Duke University
Primary completion
May 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Cystatin C
.12; .11; .07
PRIMARY
Change in Dyspnea Assessment (RED-ROSE Substudy)
16.1; 16.2; 16.8
PRIMARY
Decongestive Changes- RED-ROSE
4526.0; 4659.9; 5177.2
PRIMARY
Cumulative Urinary Volume
8524; 8296; 8574
SECONDARY
Change in Weight
-7.40; -7.73; -7.15
SECONDARY
Worst Reported Symptom Changes-RED-ROSE
20.9; 19.6; 25.6
SECONDARY
Change in Clinical Stability- RED-ROSE
30; 34; 27
SECONDARY
Change in Serum Creatinine
0.00; 0.02; 0.02
SECONDARY
Dyspnea Visual Analog Scale Area Under the Curve
4935.8; 4997.6; 4831.4
SECONDARY
Change in Heart Failure Status
11; 5; 6
SECONDARY
Change in Treatment Response
35; 32; 48
SECONDARY
Cumulative Urinary Sodium Excretion
527.0; 539.8; 515.2
SECONDARY
Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio
-2.34; 0.23; 0.74
SECONDARY
Development of Cardio-renal Syndrome
23; 24; 28
SECONDARY
Global Visual Analog Scale Area Under the Curve
4553.4; 4703.6; 4498.3

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01132846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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