Acute Heart FailurePhase 2ROSE/RED ROSENCT01132846

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

A Phase 2 study testing Nesiritide and Dopamine in people with Acute Heart Failure, run by Duke University at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Heart Failure
What is being tested?: Nesiritide and Dopamine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 8 sitesin 2 countries
Study dates: Aug 2010to Jun 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%

Show all 24Show fewer

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

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

United States7 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Vermont- Fletcher Allen Health Care
Burlington, Vermont, 05401
Duke University Medical Center
Durham, North Carolina, 27705
Baylor College of Medicine
Houston, Texas, 77030
Minnesota Heart Failure Network
Minneapolis, Minnesota, 55415
University of Utah Health Sciences Center
Murry, Utah, 84107
Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

Canada1 site

Montreal Heart Institute
Montreal, Quebec, H1T- 1C8

Other trials in Canada

About this study

Official title: Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network ROSE Study

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.

Read the 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: Acute Heart Failure
Being tested: Placebo, Nesiritide, Dopamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
NesiritideDrug
Active Comparator: Low Dose Nesiritide
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.
DopamineDrug
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.

Study groups in NCT01132846
Study group	Role	What they receive
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 Receives: Drug: Dopamine
Placebo	Placebo comparator	Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization. Receives: 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. Receives: Drug: Nesiritide

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Cystatin C
The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.
Measured: 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
Measured: 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.
Measured: Baseline to 72 hours
Cumulative Urinary Volume
The primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours
Measured: Randomization to 72 hours

Secondary outcomes (11)

Change in Weight
Change in weight from randomization to 72 hours. Secondary Endpoint
Measured: 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)
Measured: Change from Baseline to 72 hours
Change in Clinical Stability- RED-ROSE
Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit
Measured: Baseline to 60 days
Change in Serum Creatinine
Measured: randomization to 72 hours
Dyspnea Visual Analog Scale Area Under the Curve
Range 0 to 7200 Higher is better
Measured: randomization to 72 hours
Change in Heart Failure Status
Persistent or worsening heart failure defined as need for rescue therapy.
Measured: randomization to 72 hours
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
Measured: randomization to 72 hours
Cumulative Urinary Sodium Excretion
Measured: Randomization to 72 hours
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
Measured: Randomization to 72 hours
Development of Cardio-renal Syndrome
Measured: Randomization to 72 hours
Global Visual Analog Scale Area Under the Curve
Range 0 to 7200 Higher is better/improved
Measured: Randomization to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jun 2013

First posted28 May 2010 (estimated)
Study startAug 2010
Primary completionMay 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Acute Heart FailureStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01132846
Sponsor's protocol ID: Pro00024136
Other IDs: U01HL084904, Pro00029908, Pro00023578
Acronym: ROSE/RED ROSE
Status last verified: Aug 2014
First submitted: 27 May 2010
Last updated: 21 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 24247300
Adel FW, Rikhi A, Wan SH, Iyer SR, Chakraborty H, McNulty S, Tang WHW, Felker GM, Givertz MM, Chen HH. Annexin A1 is a Potential Novel Biomarker of Congestion in Acute Heart Failure. J Card Fail. 2020 Aug;26(8):727-732. doi: 10.1016/j.cardfail.2020.05.012. Epub 2020 May 27.
PubMed 32473378
Kelly JP, Cooper LB, Gallup D, Anstrom KJ, Chen HH, Redfield MM, O'Connor CM, Mentz RJ, Hernanadez AF, Felker GM. Implications of Using Different Definitions on Outcomes in Worsening Heart Failure. Circ Heart Fail. 2016 Aug;9(8):e003048. doi: 10.1161/CIRCHEARTFAILURE.116.003048.
PubMed 27514750
Wan SH, Stevens SR, Borlaug BA, Anstrom KJ, Deswal A, Felker GM, Givertz MM, Bart BA, Tang WH, Redfield MM, Chen HH. Differential Response to Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure With Reduced or Preserved Ejection Fraction: Results From the ROSE AHF Trial (Renal Optimization Strategies Evaluation in Acute Heart Failure). Circ Heart Fail. 2016 Aug;9(8):10.1161/CIRCHEARTFAILURE.115.002593 e002593. doi: 10.1161/CIRCHEARTFAILURE.115.002593.
PubMed 27512103
de Denus S, Rouleau JL, Mann DL, Huggins GS, Cappola TP, Shah SH, Keleti J, Zada YF, Provost S, Bardhadi A, Phillips MS, Normand V, Mongrain I, Dube MP. A pharmacogenetic investigation of intravenous furosemide in decompensated heart failure: a meta-analysis of three clinical trials. Pharmacogenomics J. 2017 Mar;17(2):192-200. doi: 10.1038/tpj.2016.4. Epub 2016 Mar 1.
PubMed 26927285
Chen HH, AbouEzzeddine OF, Anstrom KJ, Givertz MM, Bart BA, Felker GM, Hernandez AF, Lee KL, Braunwald E, Redfield MM; Heart Failure Clinical Research Network. Targeting the kidney in acute heart failure: can old drugs provide new benefit? Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE AHF) trial. Circ Heart Fail. 2013 Sep 1;6(5):1087-94. doi: 10.1161/CIRCHEARTFAILURE.113.000347. No abstract available.
PubMed 24046475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)

All Acute Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network ROSE Study
ClinicalTrials.gov ID: NCT01132846
Acronym / sponsor ID: ROSE/RED ROSE / Pro00024136
Conditions: Acute Heart Failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Aug 2010
Primary completion: May 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 28 May 2010 (estimated)
Results: Posted 21 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low dose Dopamine	Active comparator	Drug: DopamineDrug: Dopamine Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Placebo	Placebo comparator	Other: PlaceboDrug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Low Dose Nesiritide	Active comparator	Drug: NesiritideParticipants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboParticipants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.	Other	Placebo
NesiritideActive Comparator: Low Dose Nesiritide 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.	Drug	Low Dose Nesiritide
DopamineParticipants 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	Low dose Dopamine

Primary outcome

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

11 secondary outcomes

Change in Weight
Time frame: randomization to 72 hours
Worst Reported Symptom Changes-RED-ROSE
Time frame: Change from Baseline to 72 hours
Change in Clinical Stability- RED-ROSE
Time frame: Baseline to 60 days
Change in Serum Creatinine
Time frame: randomization to 72 hours
Dyspnea Visual Analog Scale Area Under the Curve
Time frame: randomization to 72 hours
Change in Heart Failure Status
Time frame: randomization to 72 hours
Change in Treatment Response
Time frame: randomization to 72 hours
Cumulative Urinary Sodium Excretion
Time frame: Randomization to 72 hours
Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio
Time frame: Randomization to 72 hours
Development of Cardio-renal Syndrome
Time frame: Randomization to 72 hours
Global Visual Analog Scale Area Under the Curve
Time frame: Randomization to 72 hours

Results and safety

Results posted to the registry on 21 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose Dopamine	122	106
Placebo	119	101
Low Dose Nesiritide	119	108

Primary outcome: Change in Cystatin C

Time frame: Randomization to 72 hours. Mean (Standard Deviation). Unit: mg/L

Measure	Low Dose Dopamine n = 122	Placebo n = 119	Low Dose Nesiritide n = 119
Value	.12 (.32)	.11 (.27)	.07 (.34)

Primary outcome: Change in Dyspnea Assessment (RED-ROSE Substudy)

Time frame: Baseline to 72 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Low Dose Dopamine n = 70	Placebo n = 70	Low Dose Nesiritide n = 73
Value	16.1 (30.7)	16.2 (22.3)	16.8 (24.2)

Primary outcome: Decongestive Changes- RED-ROSE

Time frame: Baseline to 72 hours. Mean (Standard Deviation). Unit: mL

Measure	Low Dose Dopamine n = 74	Placebo n = 72	Low Dose Nesiritide n = 72
Value	4526.0 (3191.9)	4659.9 (2862.5)	5177.2 (2830.5)

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

Primary outcome: Cumulative Urinary Volume

Time frame: Randomization to 72 hours. Mean (Standard Deviation). Unit: mL

Measure	Low Dose Dopamine n = 122	Placebo n = 119	Low Dose Nesiritide n = 119
Value	8524 (3418)	8296 (2973)	8574 (3115)

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose Dopamine	30 of 122 (24.6%)	0 of 122 (0%)	Not reported
Placebo	24 of 119 (20.2%)	0 of 119 (0%)	Not reported
Low Dose Nesiritide	21 of 119 (17.6%)	0 of 119 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24247300Chen 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.
Derived from this study: PubMed 32473378Adel FW, Rikhi A, Wan SH, Iyer SR, Chakraborty H, McNulty S, Tang WHW, Felker GM, Givertz MM, Chen HH. Annexin A1 is a Potential Novel Biomarker of Congestion in Acute Heart Failure. J Card Fail. 2020 Aug;26(8):727-732. doi: 10.1016/j.cardfail.2020.05.012. Epub 2020 May 27.
Derived from this study: PubMed 27514750Kelly JP, Cooper LB, Gallup D, Anstrom KJ, Chen HH, Redfield MM, O'Connor CM, Mentz RJ, Hernanadez AF, Felker GM. Implications of Using Different Definitions on Outcomes in Worsening Heart Failure. Circ Heart Fail. 2016 Aug;9(8):e003048. doi: 10.1161/CIRCHEARTFAILURE.116.003048.
Derived from this study: PubMed 27512103Wan SH, Stevens SR, Borlaug BA, Anstrom KJ, Deswal A, Felker GM, Givertz MM, Bart BA, Tang WH, Redfield MM, Chen HH. Differential Response to Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure With Reduced or Preserved Ejection Fraction: Results From the ROSE AHF Trial (Renal Optimization Strategies Evaluation in Acute Heart Failure). Circ Heart Fail. 2016 Aug;9(8):10.1161/CIRCHEARTFAILURE.115.002593 e002593. doi: 10.1161/CIRCHEARTFAILURE.115.002593.
Derived from this study: PubMed 26927285de Denus S, Rouleau JL, Mann DL, Huggins GS, Cappola TP, Shah SH, Keleti J, Zada YF, Provost S, Bardhadi A, Phillips MS, Normand V, Mongrain I, Dube MP. A pharmacogenetic investigation of intravenous furosemide in decompensated heart failure: a meta-analysis of three clinical trials. Pharmacogenomics J. 2017 Mar;17(2):192-200. doi: 10.1038/tpj.2016.4. Epub 2016 Mar 1.
Derived from this study: PubMed 24046475Chen HH, AbouEzzeddine OF, Anstrom KJ, Givertz MM, Bart BA, Felker GM, Hernandez AF, Lee KL, Braunwald E, Redfield MM; Heart Failure Clinical Research Network. Targeting the kidney in acute heart failure: can old drugs provide new benefit? Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE AHF) trial. Circ Heart Fail. 2013 Sep 1;6(5):1087-94. doi: 10.1161/CIRCHEARTFAILURE.113.000347. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kerry L Lee, PhD principal investigator

Duke University

Eugene Braunwald, MD study chair

Harvard University

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nesiritide and Dopamine in people with Acute Heart Failure, run by Duke University at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cystatin C (time frame: Randomization to 72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01132846, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.