Renal Optimization Strategies Evaluation in Acute Heart F... | NCT01132846

NCT01132846

ID	Type	Description	Link
U01HL084904	U.S. NIH Grant/Contract		View source
Pro00029908	Other Identifier	RED ROSE Number
Pro00023578	Other Identifier	Duke

Status Module

Sponsor/Collaborators Module

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Description Module

Detailed Description

Acute heart failure (AHF) is the most common cause of hospital admission in patients over age 65, accounting for 1,000,000 admissions, over 6 million hospital days, and $12 billion in costs annually. The prognosis of patients admitted with AHF is dismal, with a 20-30% readmission rate and a 20-30% mortality rate within six months after admission. Recent studies have established the prognostic importance of renal function in patients with heart failure. In patients who are hospitalized with decompensated congestive heart failure, worsening renal function is also associated with worse outcome, Various studies have estimated that 25-30% of patients hospitalized for decompensated CHF have worsening of renal function leading to prolonged hospitalization, increased morbidity and mortality. Although there are no FDA approved renal adjuvant therapies for AHF, several novel adjuvant therapies for use in AHF are being investigated in randomized clinical trials. Additionally, there are currently available strategies, with the potential for improving renal function in AHF such as low dose dopamine and low dose nesiritide. However, these strategies have not been investigated.

Participation in this study will last 6 months. All potential participants will undergo initial screening, which wil include a medical history, physical exam, blood draws, measurements of fluid intake and output, and questionnaires. The same evaluations and procedures will be repeated at various points during the study. Eligible participants will be randomly assigned to receive low dose nesiritide or placebo with optimal diuretic dosing or low dose dopamine or placebo with optimal diuretic dosing.

Follow-up assessments will occur at Baseline, 24 hours, 48 hours, 72 hours, day 7 or discharge, day 60 and 6 months. Follow-up assessments will include medical history, physical exam, blood draws, measurements of fluid intake and output, questionnaires and questions about medications and changes in health.

The RED ROSE substudy involves a subset of ROSE patients in looking at the dyspnea assessment. The dyspnea visual analog scale (dyspnea VAS) has been suggested to be superior to other ordinal (Likert) scales in assessment of dyspnea in acute heart failure syndromes (AHFS)1. However, there is no standardization of conditions (oxygen supplementation, position, activity) at the time of VAS assessment and thus, it may not optimally reflect the variability in dyspnea severity in AHFS patients. This insensitivity to variability at baseline and subsequent assessment may limit the ability to reflect variation in response over time and with alternate treatment strategies. A standardized and sequentially provocative assessment of dyspnea (provocative dyspnea severity score, pDSS) may better reflect variation in dyspnea severity and variation in response over time and with alternate treatment strategies. Substudy subjects will be asked to complete a provocative dyspnea assessment at baseline, 24, 48 and 72 hours. The subjects will be asked to complete a 6 minute walk assessment at the 72 hour visit.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose Dopamine	Active Comparator	Drug: Dopamine Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study	Drug: Dopamine
Placebo	Placebo Comparator	Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.	Other: Placebo
Low Dose Nesiritide	Active Comparator	Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.	Drug: Nesiritide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Cystatin C	The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.	Randomization to 72 hours
Change in Dyspnea Assessment (RED-ROSE Substudy)	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	Baseline to 72 hours
Decongestive Changes- RED-ROSE	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.	Baseline to 72 hours
Cumulative Urinary Volume	The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours	Randomization to 72 hours

Secondary Outcomes

Measure	Description	Time Frame
Change in Weight	Change in weight from randomization to 72 hours. Secondary Endpoint	randomization to 72 hours
Worst Reported Symptom Changes-RED-ROSE	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)

Eligibility Module

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

Contacts/Locations Module

Name	Affiliation	Role
Kerry L Lee, PhD	Duke University	Principal Investigator
Eugene Braunwald, MD	Harvard University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Brigham and Women's Hospital		Boston	Massachusetts	02115	United States
Minnesota Heart Failure Network

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24247300	Result	Chen HH, Anstrom KJ, Givertz MM, Stevenson LW, Semigran MJ, Goldsmith SR, Bart BA, Bull DA, Stehlik J, LeWinter MM, Konstam MA, Huggins GS, Rouleau JL, O'Meara E, Tang WH, Starling RC, Butler J, Deswal A, Felker GM, O'Connor CM, Bonita RE, Margulies KB, Cappola TP, Ofili EO, Mann DL, Davila-Roman VG, McNulty SE, Borlaug BA, Velazquez EJ, Lee KL, Shah MR, Hernandez AF, Braunwald E, Redfield MM; NHLBI Heart Failure Clinical Research Network. Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial. JAMA. 2013 Dec 18;310(23):2533-43. doi: 10.1001/jama.2013.282190.
32473378

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00071.0± 11.1 BG00169.3± 12.6 BG00268.3± 13.0 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00038 BG00130 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0003 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0006 BG0015 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Cystatin C

The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.

Posted

Mean

Standard Deviation

mg/L

Randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG000122 OG001119 OG002119

Title

Denominators

Categories

Title	Measurements
	OG000.12± .32 OG001.11± .27 OG002.07± .34

Primary

Change in Dyspnea Assessment (RED-ROSE Substudy)

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

Posted

Mean

Standard Deviation

units on a scale

Baseline to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Decongestive Changes- RED-ROSE

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.

RED-ROSE is a substudy of the overall ROSE study. Only consented and enrolled RED-ROSE subjects participated.

Posted

Mean

Standard Deviation

Baseline to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Primary

Cumulative Urinary Volume

The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours

Posted

Mean

Standard Deviation

Randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Change in Weight

Change in weight from randomization to 72 hours. Secondary Endpoint

Posted

Mean

Standard Deviation

lbs

randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Worst Reported Symptom Changes-RED-ROSE

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)

RED-ROSE was a substudy of the main ROSE study. Only subjects consented and enrolled in RED-ROSE were included in this analysis.

Posted

Mean

Standard Deviation

units on a scale

Change from Baseline to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Change in Clinical Stability- RED-ROSE

Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit

RED-ROSE was a substudy of the main ROSE trial. Only subjects consented and enrolled in RED-ROSE were included in this analysis.

Posted

Number

participants

Baseline to 60 days

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Change in Serum Creatinine

Posted

Mean

Standard Deviation

mg/dL

randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units

Secondary

Dyspnea Visual Analog Scale Area Under the Curve

Range 0 to 7200 Higher is better

Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.

Posted

Mean

Standard Deviation

units on a scale * hours

randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Change in Heart Failure Status

Persistent or worsening heart failure defined as need for rescue therapy.

Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.

Posted

Number

participants

randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Change in Treatment Response

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

Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.

Posted

Number

participants

randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Cumulative Urinary Sodium Excretion

Posted

Mean

Standard Deviation

mmol

Randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units

Secondary

Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio

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

No units were used in calculated the ratio

Posted

Mean

Standard Deviation

ratio

Randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Development of Cardio-renal Syndrome

Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.

Posted

Number

participants

Randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Secondary

Global Visual Analog Scale Area Under the Curve

Range 0 to 7200 Higher is better/improved

Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.

Posted

Mean

Standard Deviation

units on a scale * hours

Randomization to 72 hours

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	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.	30	122	122
EG001	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.	24	119	119
EG002	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.	21	119	119

Serious Adverse Events

Term	Organ System	Statistical Information
Anemia	Blood and lymphatic system disorders	EG0001 affected122 at risk EG0012 affected119 at risk EG0020 affected119 at risk
Hemorrhagic Anemia	Blood and lymphatic system disorders	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Acute Myocardial Infarction	Cardiac disorders	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Atrioventricular Block, Second Degree	Cardiac disorders	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Cardiac Arrest	Cardiac disorders	EG0002 affected122 at risk EG0012 affected119 at risk EG0020 affected119 at risk
Paroxysmal Arrhythmia	Cardiac disorders	EG0000 affected122 at risk EG0011 affected119 at risk EG0020 affected119 at risk
Ventricular Arrhythmia	Cardiac disorders	EG0000 affected122 at risk EG0012 affected119 at risk EG0020 affected119 at risk
Ear Pain	Ear and labyrinth disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Visual Impairment	Eye disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Abdominal Pain	Gastrointestinal disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Constipation	Gastrointestinal disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Diarrhea	Gastrointestinal disorders	EG0001 affected122 at risk EG0011 affected119 at risk EG0020 affected119 at risk
Gastroesophogeal Reflux Disease	Gastrointestinal disorders	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Lower Gastrointestinal Hemorrhage	Gastrointestinal disorders	EG0001 affected122 at risk EG0012 affected119 at risk EG0021 affected119 at risk
Melaena	Gastrointestinal disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Upper Gastrointestinal Hemorrhage	Gastrointestinal disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Vomitting	Gastrointestinal disorders	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Infusion Site Irritation	General disorders	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Chest Discomfort	General disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Chest Pain	General disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Death	General disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Cellulitis	Infections and infestations	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Influenza	Infections and infestations	EG0002 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Osteomyelitis	Infections and infestations	EG0000 affected122 at risk EG0011 affected119 at risk EG0020 affected119 at risk
Pneumonia	Infections and infestations	EG0002 affected122 at risk EG0011 affected119 at risk EG0021 affected119 at risk
Sepsis	Infections and infestations	EG0004 affected122 at risk EG0012 affected119 at risk EG0020 affected119 at risk
Septic Shock	Infections and infestations	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Upper Respiratory Tract Infections	Infections and infestations	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Fall	Injury, poisoning and procedural complications	EG0000 affected122 at risk EG0011 affected119 at risk EG0020 affected119 at risk
Procedural Complications	Injury, poisoning and procedural complications	EG0001 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Anticoagulation Drug Level Above Therapeutic	Investigations	EG0002 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Weight Decreased	Investigations	EG0000 affected122 at risk EG0011 affected119 at risk EG0020 affected119 at risk
Hypoglycemia	Metabolism and nutrition disorders	EG0002 affected122 at risk EG0011 affected119 at risk EG0021 affected119 at risk
Hyperammonaemia	Metabolism and nutrition disorders	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Cerebrovascular Accident	Nervous system disorders	EG0001 affected122 at risk EG0011 affected119 at risk EG0021 affected119 at risk
Syncope	Nervous system disorders	EG0000 affected122 at risk EG0012 affected119 at risk EG0022 affected119 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected122 at risk EG0010 affected119 at risk EG0021 affected119 at risk
Renal Failure	Renal and urinary disorders	EG0000 affected122 at risk EG0013 affected119 at risk EG0020 affected119 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0002 affected122 at risk EG0010 affected119 at risk EG0020 affected119 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	EG0002 affected122 at risk EG0011 affected119 at risk EG0020 affected119 at risk
Hypotension	Vascular disorders	EG0002 affected122 at risk EG0017 affected119 at risk EG0025 affected119 at risk

ID	Term
D020097	Natriuretic Peptide, Brain
D004298	Dopamine

Ancestor Terms

ID	Term
D045265	Natriuretic Peptides
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009419	Nerve Tissue Proteins
D011506	Proteins
D015306	Biogenic Monoamines
D001679	Biogenic Amines
D000588	Amines
D009930	Organic Chemicals
D002395	Catecholamines
D002396	Catechols
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Units	Counts
Participants	OG000122 OG001119 OG002119

Units	Counts
Participants	OG000122 OG001119 OG002119

Units	Counts
Participants	OG000122 OG001119 OG002119

Units	Counts
Participants	OG000105 OG001110 OG002111