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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01132846
First received: May 27, 2010
Last updated: August 20, 2014
Last verified: August 2014
Results First Received: July 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Heart Failure
Interventions: Other: Placebo
Drug: Nesiritide
Drug: Dopamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Low Dose Dopamine

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.

Placebo

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.

Low Dose Nesiritide

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.


Participant Flow:   Overall Study
    Low Dose Dopamine     Placebo     Low Dose Nesiritide  
STARTED     122     119     119  
COMPLETED     106     101     108  
NOT COMPLETED     16     18     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Low Dose Dopamine

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.

Placebo

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.

Low Dose Nesiritide

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 Total of all reporting groups

Baseline Measures
    Low Dose Dopamine     Placebo     Low Dose Nesiritide     Total  
Number of Participants  
[units: participants]
  122     119     119     360  
Age  
[units: years]
Mean ± Standard Deviation
  71.0  ± 11.1     69.3  ± 12.6     68.3  ± 13.0     69.6  ± 12.3  
Gender  
[units: participants]
       
Female     38     30     28     96  
Male     84     89     91     264  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     3     1     3     7  
Asian     1     1     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     27     23     24     74  
White     90     91     91     272  
More than one race     1     1     0     2  
Unknown or Not Reported     0     2     0     2  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     6     5     3     14  
Not Hispanic or Latino     116     112     116     344  
Unknown or Not Reported     0     2     0     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Cystatin C   [ Time Frame: Randomization to 72 hours ]

2.  Primary:   Change in Dyspnea Assessment (RED-ROSE Substudy)   [ Time Frame: Baseline to 72 hours ]

3.  Primary:   Decongestive Changes- RED-ROSE   [ Time Frame: Baseline to 72 hours ]

4.  Primary:   Cumulative Urinary Volume   [ Time Frame: Randomization to 72 hours ]

5.  Secondary:   Change in Weight   [ Time Frame: randomization to 72 hours ]

6.  Secondary:   Worst Reported Symptom Changes-RED-ROSE   [ Time Frame: Change from Baseline to 72 hours ]

7.  Secondary:   Change in Clinical Stability- RED-ROSE   [ Time Frame: Baseline to 60 days ]

8.  Secondary:   Change in Serum Creatinine   [ Time Frame: randomization to 72 hours ]

9.  Secondary:   Dyspnea Visual Analog Scale Area Under the Curve   [ Time Frame: randomization to 72 hours ]

10.  Secondary:   Change in Heart Failure Status   [ Time Frame: randomization to 72 hours ]

11.  Secondary:   Change in Treatment Response   [ Time Frame: randomization to 72 hours ]

12.  Secondary:   Cumulative Urinary Sodium Excretion   [ Time Frame: Randomization to 72 hours ]

13.  Secondary:   Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio   [ Time Frame: Randomization to 72 hours ]

14.  Secondary:   Development of Cardio-renal Syndrome   [ Time Frame: Randomization to 72 hours ]

15.  Secondary:   Global Visual Analog Scale Area Under the Curve   [ Time Frame: Randomization to 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Kevin Anstrom
Organization: Duke University
phone: 919-668-8902
e-mail: kevin.anstrom@dm.duke.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01132846     History of Changes
Other Study ID Numbers: Pro00024136, U01HL084904, Pro00029908, Pro00023578
Study First Received: May 27, 2010
Results First Received: July 7, 2014
Last Updated: August 20, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board