Heart FailurePhase 3NCT00577135
Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)
A Phase 3 study testing Furosemide-Q12 hour bolus, Furosemide-Continuous Infusion and Furosemide-Low Intensification in people with Heart Failure, run by Duke University at 9 sites in 2 countries.
Trial summary
Heart failure is a disorder in which the heart does not pump blood adequately. This can lead to several serious problems, including reduced blood flow throughout the body, congestion of blood in the veins and lungs, and fluid accumulation in various organs and limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Furosemide-Q12 hour bolus, Furosemide-Continuous Infusion and Furosemide-Low Intensification
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2008to Feb 2010
- Phase
- Phase 3
- 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
- Prior clinical diagnosis of heart failure that was treated with daily oral loop diuretics for at least 1 month
- Current 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)
- Daily oral dose of furosemide between 80 mg and 240 mg (or equivalent)
- Identified within 24 hours of hospital admission
- Current treatment plan includes IV loop diuretics for at least 48 hours
Who cannot join
- Brain natriuretic peptide (BNP) less than 250 mg/mL or N-terminal prohormone brain natriuretic peptide (NT-proBNP) less than 1000 mg/mL
- Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
- Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for heart failure
- Substantial diuretic response to pre-randomization diuretic dosing such that higher doses of diuretics would be medically inadvisable
- Systolic blood pressure less than 90 mm Hg
- Serum creatinine level greater than 3.0 mg/dL at baseline or currently undergoing renal replacement therapy
Show all 23Show fewer
- Hemodynamically significant arrhythmias
- Acute coronary syndrome within 4 weeks prior to study entry
- Active myocarditis
- Hypertrophic obstructive cardiomyopathy
- Severe 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 heart failure) with expected survival time of less than 1 year
- History of adverse reaction to the study drugs
- Use of IV iodinated radiocontrast material within 72 hours prior to study entry or planned during hospitalization
- Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
- Inability to comply with planned study procedures
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Morehouse School of Medicine
Atlanta, Georgia, 30310
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
Murray, Utah, 84107
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Diuretic Optimal Strategy Evaluation in Acute Heart Failure (The DOSE-AHF Study)
Heart failure is a disorder in which the heart does not pump blood adequately. This can lead to several serious problems, including reduced blood flow throughout the body, congestion of blood in the veins and lungs, and fluid accumulation in various organs and limbs. Diuretics are often used to address the problem of fluid accumulation, but the optimal dose and the amount of time over which to administer each dose are unclear. This study will compare high and low doses of diuretics administered over longer and shorter periods of time to determine the safest and most effective combination.
Read the detailed description
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Heart failure symptoms include shortness of breath, swelling, and fatigue. Standard treatment for the swelling associated with heart failure includes the use of diuretic medications, such as furosemide, which cause urination and the removal of excess fluids in the body. Although furosemide has been used to treat heart failure patients for many years, it is still unclear how much of the drug to use, and over what time period the drug should be given. This study will evaluate whether furosemide treatment is safer and more effective when the drug is given in high doses versus low doses and in two to three separate doses versus one continuous infusion.
Participants in this study will begin study procedures within the first 24 hours of their hospital admission for heart failure. Participants will be randomly assigned to receive one of the following four treatments: high dose furosemide via continuous intravenous (IV) infusion and placebo every 12 hours via IV bolus; low dose furosemide via continuous IV infusion and placebo every 12 hours via IV bolus; high dose furosemide every 12 hours via IV bolus and placebo via continuous IV infusion; and low dose furosemide every 12 hours via IV bolus and placebo via continuous IV infusion. Each participant will receive treatment for the first 72 hours of his or her hospital stay. Participants will answer questionnaires and undergo physical examinations and blood tests during the first 96 hours of hospitalization and again before hospital discharge or on Day 7, if that occurs first. Participants will be asked to return to their doctors 60 days following hospital discharge to evaluate their responses to treatment.
- Conditions
- Heart Failure
- Being tested
- Furosemide-Q12 hour bolus, Furosemide-Continuous Infusion, Furosemide-Low Intensification, Furosemide-High Intensification
- Keywords
- Loop Diuretics, Furosemide, Fluid Overload, Cardio Renal Failure
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide-Q12 hour bolusDrug
Also called Loop diuretics
Q12 hours bolus
Furosemide-Continuous InfusionDrug
Also called Loop diuretic
Continuous infusion
Furosemide-Low IntensificationDrug
Also called Loop diuretic
1x oral dose
Furosemide-High IntensificationDrug
Also called loop diuretic
2.5x oral dose
| Study group | Role | What they receive |
|---|---|---|
| Q12 hour bolus | Experimental | Furosemide-Q12 hour bolus Receives: Drug: Furosemide-Low Intensification; Drug: Furosemide-High Intensification |
| Continuous Infusion | Experimental | Furosemide-Continuous Infusion Receives: Drug: Furosemide-Low Intensification; Drug: Furosemide-High Intensification |
| Low Intensification | Experimental | Furosemide-Low Intensification Receives: Drug: Furosemide-Q12 hour bolus; Drug: Furosemide-Continuous Infusion |
| High Intensification | Experimental | Furosemide-High Intensification Receives: Drug: Furosemide-Q12 hour bolus; Drug: Furosemide-Continuous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Well Being, as Determined by a Visual Analog Scale
Global Visual Analog Scale Scale Range 0-7200; higher score is better
Measured: Measured at 72 hours
Change in Serum Creatinine
Measured: Measured at baseline and 72 hours
Secondary outcomes (26)
Change in Weight
Measured: baseline and 96 hours
Proportion of Patients Free of Congestion
Measured: Measured at 72 hours
Dyspnea, as Determined by Visual Analog Scales
Global Visual Analog Scale Scale Range 0-2400; higher score is better
Measured: Measured at 24 hours
Change in Serum Creatinine
Measured: baseline and 24 hours
Change in Cystatin C
Measured: baseline and 72 hours
Change in Serum Creatinine
Measured: baseline and 48 hours
Change in Serum Creatinine
Measured: baseline and 96 hours
Change in Serum Creatinine
Measured: baseline and day 7
Change in Serum Creatinine
Measured: baseline and day 60
Patient Well Being, as Determined by a Visual Analog Scale
Global Visual Analog Scale Scale Range 0-2400; higher score is better
Measured: Measured at 24 hours
Patient Well Being, as Determined by a Visual Analog Scale
Global Visual Analog Scale Scale Range 0-4800; higher score is better
Measured: 48 hours
Dyspnea VAS
Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better
Measured: 48 hours
Dyspnea VAS
Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better
Measured: 72 hours
Change in Cystatin C
Measured: baseline and day 7
Change in Cystatin C
Measured: baseline and day 60
Change in Uric Acid
Measured: baseline and 72 hours
Change in Uric Acid
Measured: baseline and day 7
Change in Uric Acid
Measured: baseline and Day 60
Change in B-type Natriuretic Peptide
Change in NTproBNP
Measured: baseline and 72 hours
Change in NTproBNP
Measured: baseline and Day 7
Change in NTproBNP
Measured: baseline and Day 60
Presence of Cardiorenal Syndrome
Measured: Within 72 hours
Treatment Failure
Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization
Measured: Within 72 hours
Net Fluid Loss
Measured: Through 24 hours
Net Fluid Loss
Measured: Through 48 hours
Net Fluid Loss
Measured: Through 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionJan 2010
- Study completionFeb 2010
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 (8)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kerry L. Lee, PhD, Principal investigator, Duke Clinical Research InstituteEugene Braunwald, MD, Study chair, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577135
- Sponsor's protocol ID
- Pro00017634
- Other IDs
- U01HL084904-01
- Status last verified
- Apr 2013
- First submitted
- 18 Dec 2007
- Last updated
- 6 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
PubMed 21366472Rasoul D, Zhang J, Farnell E, Tsangarides AA, Chong SC, Fernando R, Zhou C, Ihsan M, Ahmed S, Lwin TS, Bateman J, Hill RA, Lip GY, Sankaranarayanan R. Continuous infusion versus bolus injection of loop diuretics for acute heart failure. Cochrane Database Syst Rev. 2024 May 22;5(5):CD014811. doi: 10.1002/14651858.CD014811.pub2.
PubMed 38775253Kelly 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 27514750de 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 26927285Lala A, McNulty SE, Mentz RJ, Dunlay SM, Vader JM, AbouEzzeddine OF, DeVore AD, Khazanie P, Redfield MM, Goldsmith SR, Bart BA, Anstrom KJ, Felker GM, Hernandez AF, Stevenson LW. Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF). Circ Heart Fail. 2015 Jul;8(4):741-8. doi: 10.1161/CIRCHEARTFAILURE.114.001957. Epub 2015 Jun 3.
PubMed 26041600Mentz RJ, Stevens SR, DeVore AD, Lala A, Vader JM, AbouEzzeddine OF, Khazanie P, Redfield MM, Stevenson LW, O'Connor CM, Goldsmith SR, Bart BA, Anstrom KJ, Hernandez AF, Braunwald E, Felker GM. Decongestion strategies and renin-angiotensin-aldosterone system activation in acute heart failure. JACC Heart Fail. 2015 Feb;3(2):97-107. doi: 10.1016/j.jchf.2014.09.003. Epub 2014 Oct 31.
PubMed 25543972Kociol RD, McNulty SE, Hernandez AF, Lee KL, Redfield MM, Tracy RP, Braunwald E, O'Connor CM, Felker GM; NHLBI Heart Failure Network Steering Committee and Investigators. Markers of decongestion, dyspnea relief, and clinical outcomes among patients hospitalized with acute heart failure. Circ Heart Fail. 2013 Mar;6(2):240-5. doi: 10.1161/CIRCHEARTFAILURE.112.969246. Epub 2012 Dec 18.
PubMed 23250981Shah RV, McNulty S, O'Connor CM, Felker GM, Braunwald E, Givertz MM. Effect of admission oral diuretic dose on response to continuous versus bolus intravenous diuretics in acute heart failure: an analysis from diuretic optimization strategies in acute heart failure. Am Heart J. 2012 Dec;164(6):862-8. doi: 10.1016/j.ahj.2012.08.019. Epub 2012 Oct 29.
PubMed 23194486
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuretic Optimal Strategy Evaluation in Acute Heart Failure (The DOSE-AHF Study)
- ClinicalTrials.gov ID
- NCT00577135
- Acronym / sponsor ID
- Pro00017634
- Conditions
- Heart Failure
- Keywords
- Loop Diuretics, Furosemide, Fluid Overload, Cardio Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure is a disorder in which the heart does not pump blood adequately. This can lead to several serious problems, including reduced blood flow throughout the body, congestion of blood in the veins and lungs, and fluid accumulation in various organs and limbs. Diuretics are often used to address the problem of fluid accumulation, but the optimal dose and the amount of time over which to administer each dose are unclear. This study will compare high and low doses of diuretics administered over longer and shorter periods of time to determine the safest and most effective combination.
Detailed description
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Heart failure symptoms include shortness of breath, swelling, and fatigue. Standard treatment for the swelling associated with heart failure includes the use of diuretic medications, such as furosemide, which cause urination and the removal of excess fluids in the body. Although furosemide has been used to treat heart failure patients for many years, it is still unclear how much of the drug to use, and over what time period the drug should be given. This study will evaluate whether furosemide treatment is safer and more effective when the drug is given in high doses versus low doses and in two to three separate doses versus one continuous infusion.
Participants in this study will begin study procedures within the first 24 hours of their hospital admission for heart failure. Participants will be randomly assigned to receive one of the following four treatments: high dose furosemide via continuous intravenous (IV) infusion and placebo every 12 hours via IV bolus; low dose furosemide via continuous IV infusion and placebo every 12 hours via IV bolus; high dose furosemide every 12 hours via IV bolus and placebo via continuous IV infusion; and low dose furosemide every 12 hours via IV bolus and placebo via continuous IV infusion. Each participant will receive treatment for the first 72 hours of his or her hospital stay. Participants will answer questionnaires and undergo physical examinations and blood tests during the first 96 hours of hospitalization and again before hospital discharge or on Day 7, if that occurs first. Participants will be asked to return to their doctors 60 days following hospital discharge to evaluate their responses to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Q12 hour bolus | Experimental | Drug: Furosemide-Low Intensification, Drug: Furosemide-High IntensificationFurosemide-Q12 hour bolus |
| Continuous Infusion | Experimental | Drug: Furosemide-Low Intensification, Drug: Furosemide-High IntensificationFurosemide-Continuous Infusion |
| Low Intensification | Experimental | Drug: Furosemide-Q12 hour bolus, Drug: Furosemide-Continuous InfusionFurosemide-Low Intensification |
| High Intensification | Experimental | Drug: Furosemide-Q12 hour bolus, Drug: Furosemide-Continuous InfusionFurosemide-High Intensification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prior clinical diagnosis of heart failure that was treated with daily oral loop diuretics for at least 1 month
- Current 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)
- Daily oral dose of furosemide between 80 mg and 240 mg (or equivalent)
- Identified within 24 hours of hospital admission
- Current treatment plan includes IV loop diuretics for at least 48 hours
Key exclusion criteria (23 listed)
- Brain natriuretic peptide (BNP) less than 250 mg/mL or N-terminal prohormone brain natriuretic peptide (NT-proBNP) less than 1000 mg/mL
- Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
- Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for heart failure
- Substantial diuretic response to pre-randomization diuretic dosing such that higher doses of diuretics would be medically inadvisable
- Systolic blood pressure less than 90 mm Hg
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 |
|---|---|---|
| Furosemide-Q12 hour bolusAlso: Loop diureticsQ12 hours bolus | Drug | High Intensification, Low Intensification |
| Furosemide-Continuous InfusionAlso: Loop diureticContinuous infusion | Drug | High Intensification, Low Intensification |
| Furosemide-Low IntensificationAlso: Loop diuretic1x oral dose | Drug | Continuous Infusion, Q12 hour bolus |
| Furosemide-High IntensificationAlso: loop diuretic2.5x oral dose | Drug | Continuous Infusion, Q12 hour bolus |
Primary outcome
Patient Well Being, as Determined by a Visual Analog Scale
Time frame: Measured at 72 hours
Global Visual Analog Scale Scale Range 0-7200; higher score is better
Change in Serum Creatinine
Time frame: Measured at baseline and 72 hours
26 secondary outcomes
Change in Weight
Time frame: baseline and 96 hours
Proportion of Patients Free of Congestion
Time frame: Measured at 72 hours
Dyspnea, as Determined by Visual Analog Scales
Time frame: Measured at 24 hours
Change in Serum Creatinine
Time frame: baseline and 24 hours
Change in Cystatin C
Time frame: baseline and 72 hours
Change in Serum Creatinine
Time frame: baseline and 48 hours
Change in Serum Creatinine
Time frame: baseline and 96 hours
Change in Serum Creatinine
Time frame: baseline and day 7
Change in Serum Creatinine
Time frame: baseline and day 60
Patient Well Being, as Determined by a Visual Analog Scale
Time frame: Measured at 24 hours
Patient Well Being, as Determined by a Visual Analog Scale
Time frame: 48 hours
Dyspnea VAS
Time frame: 48 hours
Dyspnea VAS
Time frame: 72 hours
Change in Cystatin C
Time frame: baseline and day 7
Change in Cystatin C
Time frame: baseline and day 60
Change in Uric Acid
Time frame: baseline and 72 hours
Change in Uric Acid
Time frame: baseline and day 7
Change in Uric Acid
Time frame: baseline and Day 60
Change in B-type Natriuretic Peptide
Time frame: baseline and 72 hours
Change in NTproBNP
Time frame: baseline and Day 7
Change in NTproBNP
Time frame: baseline and Day 60
Presence of Cardiorenal Syndrome
Time frame: Within 72 hours
Treatment Failure
Time frame: Within 72 hours
Net Fluid Loss
Time frame: Through 24 hours
Net Fluid Loss
Time frame: Through 48 hours
Net Fluid Loss
Time frame: Through 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21366472Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
- Derived from this study: PubMed 38775253Rasoul D, Zhang J, Farnell E, Tsangarides AA, Chong SC, Fernando R, Zhou C, Ihsan M, Ahmed S, Lwin TS, Bateman J, Hill RA, Lip GY, Sankaranarayanan R. Continuous infusion versus bolus injection of loop diuretics for acute heart failure. Cochrane Database Syst Rev. 2024 May 22;5(5):CD014811. doi: 10.1002/14651858.CD014811.pub2.
- 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 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 26041600Lala A, McNulty SE, Mentz RJ, Dunlay SM, Vader JM, AbouEzzeddine OF, DeVore AD, Khazanie P, Redfield MM, Goldsmith SR, Bart BA, Anstrom KJ, Felker GM, Hernandez AF, Stevenson LW. Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF). Circ Heart Fail. 2015 Jul;8(4):741-8. doi: 10.1161/CIRCHEARTFAILURE.114.001957. Epub 2015 Jun 3.
- Derived from this study: PubMed 25543972Mentz RJ, Stevens SR, DeVore AD, Lala A, Vader JM, AbouEzzeddine OF, Khazanie P, Redfield MM, Stevenson LW, O'Connor CM, Goldsmith SR, Bart BA, Anstrom KJ, Hernandez AF, Braunwald E, Felker GM. Decongestion strategies and renin-angiotensin-aldosterone system activation in acute heart failure. JACC Heart Fail. 2015 Feb;3(2):97-107. doi: 10.1016/j.jchf.2014.09.003. Epub 2014 Oct 31.
- Derived from this study: PubMed 23250981Kociol RD, McNulty SE, Hernandez AF, Lee KL, Redfield MM, Tracy RP, Braunwald E, O'Connor CM, Felker GM; NHLBI Heart Failure Network Steering Committee and Investigators. Markers of decongestion, dyspnea relief, and clinical outcomes among patients hospitalized with acute heart failure. Circ Heart Fail. 2013 Mar;6(2):240-5. doi: 10.1161/CIRCHEARTFAILURE.112.969246. Epub 2012 Dec 18.
- Derived from this study: PubMed 23194486Shah RV, McNulty S, O'Connor CM, Felker GM, Braunwald E, Givertz MM. Effect of admission oral diuretic dose on response to continuous versus bolus intravenous diuretics in acute heart failure: an analysis from diuretic optimization strategies in acute heart failure. Am Heart J. 2012 Dec;164(6):862-8. doi: 10.1016/j.ahj.2012.08.019. Epub 2012 Oct 29.
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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 Clinical Research Institute
Eugene Braunwald, MD study chair
Harvard University
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide-Q12 hour bolus, Furosemide-Continuous Infusion and Furosemide-Low Intensification in people with Heart Failure, run by Duke University at 9 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 5 inclusion and 23 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 May 2013). 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?
Patient Well Being, as Determined by a Visual Analog Scale (time frame: Measured at 72 hours). The study lists 2 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 NCT00577135, which also lists 8 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 6 Mar 2018.