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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01132846
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : August 21, 2014
Last Update Posted : August 21, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Heart Failure
Interventions Other: Placebo
Drug: Nesiritide
Drug: Dopamine
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Period Title: Overall Study
Started 122 119 119
Completed 106 101 108
Not Completed 16 18 11
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide Total
Hide Arm/Group Description

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Total of all reporting groups
Overall Number of Baseline Participants 122 119 119 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 119 participants 119 participants 360 participants
71.0  (11.1) 69.3  (12.6) 68.3  (13.0) 69.6  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 119 participants 119 participants 360 participants
Female
38
  31.1%
30
  25.2%
28
  23.5%
96
  26.7%
Male
84
  68.9%
89
  74.8%
91
  76.5%
264
  73.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 119 participants 119 participants 360 participants
American Indian or Alaska Native
3
   2.5%
1
   0.8%
3
   2.5%
7
   1.9%
Asian
1
   0.8%
1
   0.8%
1
   0.8%
3
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
27
  22.1%
23
  19.3%
24
  20.2%
74
  20.6%
White
90
  73.8%
91
  76.5%
91
  76.5%
272
  75.6%
More than one race
1
   0.8%
1
   0.8%
0
   0.0%
2
   0.6%
Unknown or Not Reported
0
   0.0%
2
   1.7%
0
   0.0%
2
   0.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 119 participants 119 participants 360 participants
Hispanic or Latino
6
   4.9%
5
   4.2%
3
   2.5%
14
   3.9%
Not Hispanic or Latino
116
  95.1%
112
  94.1%
116
  97.5%
344
  95.6%
Unknown or Not Reported
0
   0.0%
2
   1.7%
0
   0.0%
2
   0.6%
1.Primary Outcome
Title Change in Cystatin C
Hide Description The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.
Time Frame Randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 122 119 119
Mean (Standard Deviation)
Unit of Measure: mg/L
.12  (.32) .11  (.27) .07  (.34)
2.Primary Outcome
Title Change in Dyspnea Assessment (RED-ROSE Substudy)
Hide Description

To determine whether the pDSS is a more sensitive index of variability in dyspnea status than the dyspnea VAS assessed without standardization of conditions at assessment as assessed by change in Dyspnea VAS.

Dyspnea VAS range -100 to + 100 Larger number is better

Time Frame Baseline to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 70 70 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.1  (30.7) 16.2  (22.3) 16.8  (24.2)
3.Primary Outcome
Title Decongestive Changes- RED-ROSE
Hide Description

To determine whether changes in pDSS or dyspnea VAS are related to the response to decongestive therapy as evidenced by fluid volume loss

Fluid volume loss is defined as cumulative urinary output minus fluid intake during the first 72 hours post randomization.

Time Frame Baseline to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
RED-ROSE is a substudy of the overall ROSE study. Only consented and enrolled RED-ROSE subjects participated.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 74 72 72
Mean (Standard Deviation)
Unit of Measure: mL
4526.0  (3191.9) 4659.9  (2862.5) 5177.2  (2830.5)
4.Primary Outcome
Title Cumulative Urinary Volume
Hide Description The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours
Time Frame Randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 122 119 119
Mean (Standard Deviation)
Unit of Measure: mL
8524  (3418) 8296  (2973) 8574  (3115)
5.Secondary Outcome
Title Change in Weight
Hide Description Change in weight from randomization to 72 hours. Secondary Endpoint
Time Frame randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 122 119 119
Mean (Standard Deviation)
Unit of Measure: lbs
-7.40  (7.94) -7.73  (7.04) -7.15  (7.80)
6.Secondary Outcome
Title Worst Reported Symptom Changes-RED-ROSE
Hide Description

To determine whether changes in worst reported symptom (WRS) (dyspnea, body swelling or fatigue) VAS (WRS-VAS) are related to the response to decongestive therapy as assessed by change in WRS VAS.

WRS range -100 to + 100 Higher number is better (improved)

Time Frame Change from Baseline to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
RED-ROSE was a substudy of the main ROSE study. Only subjects consented and enrolled in RED-ROSE were included in this analysis.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 68 70 73
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.9  (29.6) 19.6  (22.7) 25.6  (25.6)
7.Secondary Outcome
Title Change in Clinical Stability- RED-ROSE
Hide Description Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit
Time Frame Baseline to 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
RED-ROSE was a substudy of the main ROSE trial. Only subjects consented and enrolled in RED-ROSE were included in this analysis.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 76 75 76
Measure Type: Number
Unit of Measure: participants
30 34 27
8.Secondary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 122 119 119
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.00  (0.44) 0.02  (0.33) 0.02  (0.42)
9.Secondary Outcome
Title Dyspnea Visual Analog Scale Area Under the Curve
Hide Description Range 0 to 7200 Higher is better
Time Frame randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 112 114 115
Mean (Standard Deviation)
Unit of Measure: units on a scale * hours
4935.8  (1472.1) 4997.6  (1479.9) 4831.4  (1294.1)
10.Secondary Outcome
Title Change in Heart Failure Status
Hide Description Persistent or worsening heart failure defined as need for rescue therapy.
Time Frame randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 118 116 117
Measure Type: Number
Unit of Measure: participants
11 5 6
11.Secondary Outcome
Title Change in Treatment Response
Hide Description

Treatment failure including any of the following:

  • development of cardio-renal syndrome
  • worsening/persistent heart failure
  • significant hypotension requiring discontinuation of study drug
  • significant tachycardia requiring discontinuation of study drug death
Time Frame randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 117 115 119
Measure Type: Number
Unit of Measure: participants
35 32 48
12.Secondary Outcome
Title Cumulative Urinary Sodium Excretion
Hide Description [Not Specified]
Time Frame Randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 122 119 119
Mean (Standard Deviation)
Unit of Measure: mmol
527.0  (299.0) 539.8  (302.7) 515.2  (261.4)
13.Secondary Outcome
Title Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio
Hide Description

BUN measured in mg/dL Cystatin C measured in mg/L

No units were used in calculated the ratio

Time Frame Randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 122 119 119
Mean (Standard Deviation)
Unit of Measure: ratio
-2.34  (25.33) 0.23  (5.16) 0.74  (7.60)
14.Secondary Outcome
Title Development of Cardio-renal Syndrome
Hide Description [Not Specified]
Time Frame Randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 105 110 111
Measure Type: Number
Unit of Measure: participants
23 24 28
15.Secondary Outcome
Title Global Visual Analog Scale Area Under the Curve
Hide Description Range 0 to 7200 Higher is better/improved
Time Frame Randomization to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description:

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

Overall Number of Participants Analyzed 112 113 114
Mean (Standard Deviation)
Unit of Measure: units on a scale * hours
4553.4  (1324.9) 4703.6  (1403.4) 4498.3  (1301.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Dopamine Placebo Low Dose Nesiritide
Hide Arm/Group Description

Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: 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.

Drug: Placebo

Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.

Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.

Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

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.

All-Cause Mortality
Low Dose Dopamine Placebo Low Dose Nesiritide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Low Dose Dopamine Placebo Low Dose Nesiritide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/122 (24.59%)   24/119 (20.17%)   21/119 (17.65%) 
Blood and lymphatic system disorders       
Anemia  1/122 (0.82%)  2/119 (1.68%)  0/119 (0.00%) 
Hemorrhagic Anemia  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Cardiac disorders       
Acute Myocardial Infarction  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Atrioventricular Block, Second Degree  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Cardiac Arrest  2/122 (1.64%)  2/119 (1.68%)  0/119 (0.00%) 
Paroxysmal Arrhythmia  0/122 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Ventricular Arrhythmia  0/122 (0.00%)  2/119 (1.68%)  0/119 (0.00%) 
Ear and labyrinth disorders       
Ear Pain  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Eye disorders       
Visual Impairment  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Gastrointestinal disorders       
Abdominal Pain  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Constipation  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Diarrhea  1/122 (0.82%)  1/119 (0.84%)  0/119 (0.00%) 
Gastroesophogeal Reflux Disease  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Lower Gastrointestinal Hemorrhage  1/122 (0.82%)  2/119 (1.68%)  1/119 (0.84%) 
Melaena  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Upper Gastrointestinal Hemorrhage  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Vomitting  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
General disorders       
Infusion Site Irritation  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Chest Discomfort  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Chest Pain  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Death  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Infections and infestations       
Cellulitis  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Influenza  2/122 (1.64%)  0/119 (0.00%)  0/119 (0.00%) 
Osteomyelitis  0/122 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Pneumonia  2/122 (1.64%)  1/119 (0.84%)  1/119 (0.84%) 
Sepsis  4/122 (3.28%)  2/119 (1.68%)  0/119 (0.00%) 
Septic Shock  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Upper Respiratory Tract Infections  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Injury, poisoning and procedural complications       
Fall  0/122 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Procedural Complications  1/122 (0.82%)  0/119 (0.00%)  0/119 (0.00%) 
Investigations       
Anticoagulation Drug Level Above Therapeutic  2/122 (1.64%)  0/119 (0.00%)  0/119 (0.00%) 
Weight Decreased  0/122 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Metabolism and nutrition disorders       
Hypoglycemia  2/122 (1.64%)  1/119 (0.84%)  1/119 (0.84%) 
Hyperammonaemia  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal Cell Carcinoma  0/122 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Nervous system disorders       
Cerebrovascular Accident  1/122 (0.82%)  1/119 (0.84%)  1/119 (0.84%) 
Syncope  0/122 (0.00%)  2/119 (1.68%)  2/119 (1.68%) 
Renal and urinary disorders       
Renal Failure  0/122 (0.00%)  3/119 (2.52%)  0/119 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute Respiratory Failure  2/122 (1.64%)  0/119 (0.00%)  0/119 (0.00%) 
Respiratory Failure  2/122 (1.64%)  1/119 (0.84%)  0/119 (0.00%) 
Vascular disorders       
Hypotension  2/122 (1.64%)  7/119 (5.88%)  5/119 (4.20%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose Dopamine Placebo Low Dose Nesiritide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/122 (0.00%)   0/119 (0.00%)   0/119 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevin Anstrom
Organization: Duke University
Phone: 919-668-8902
EMail: kevin.anstrom@dm.duke.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01132846    
Other Study ID Numbers: Pro00024136
U01HL084904 ( U.S. NIH Grant/Contract )
Pro00029908 ( Other Identifier: RED ROSE Number )
Pro00023578 ( Other Identifier: Duke )
First Submitted: May 27, 2010
First Posted: May 28, 2010
Results First Submitted: July 7, 2014
Results First Posted: August 21, 2014
Last Update Posted: August 21, 2014