Determining Optimal Dose and Duration of Diuretic Treatme... | NCT00577135

NCT00577135

ID	Type	Description	Link
U01HL084904-01	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

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

Oversight Module

Description Module

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
Q12 hour bolus	Experimental	Furosemide-Q12 hour bolus	Drug: Furosemide-Low Intensification Drug: Furosemide-High Intensification
Continuous Infusion	Experimental	Furosemide-Continuous Infusion	Drug: Furosemide-Low Intensification Drug: Furosemide-High Intensification
Low Intensification	Experimental	Furosemide-Low Intensification	Drug: Furosemide-Q12 hour bolus Drug: Furosemide-Continuous Infusion
High Intensification	Experimental	Furosemide-High Intensification	Drug: Furosemide-Q12 hour bolus Drug: Furosemide-Continuous Infusion

Name	Type	Description	Arm Group Labels	Other Names
Furosemide-Q12 hour bolus	Drug	Q12 hours bolus	High Intensification Low Intensification

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Well Being, as Determined by a Visual Analog Scale	Global Visual Analog Scale Scale Range 0-7200; higher score is better	Measured at 72 hours
Change in Serum Creatinine		Measured at baseline and 72 hours

Measure	Description	Time Frame
Change in Weight		baseline and 96 hours
Proportion of Patients Free of Congestion		Measured at 72 hours
Dyspnea, as Determined by Visual Analog Scales

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Morehouse School of Medicine		Atlanta	Georgia	30310	United States
Brigham and Women's Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21366472	Result	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.
38775253	Derived

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	Q12 Hours Bolus & Low Intensification	Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
FG001	Q12 Hours Bolus & High Intensification	High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus

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

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Q12 Hours Bolus & Low Intensification
BG001	Q12 Hours Bolus & High Intensification
BG002	Continuous Infusion & Low Intensification
BG003	Continuous Infusion & High Intensification
BG004	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
	OG0004236± 1440.4 OG0014372.7± 1404.4 OG0024170.8± 1436.3 OG003

Primary

Change in Serum Creatinine

Posted

Mean

Standard Deviation

mg/dL

Measured at baseline and 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Weight

Posted

Mean

Standard Deviation

lbs

baseline and 96 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Free of Congestion

Posted

Number

percentage of participants

Measured at 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Dyspnea, as Determined by Visual Analog Scales

Global Visual Analog Scale Scale Range 0-2400; higher score is better

Posted

Mean

Standard Deviation

units on a scale

Measured at 24 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Serum Creatinine

Posted

Mean

Standard Deviation

mg/dL

baseline and 24 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Cystatin C

Posted

Mean

Standard Deviation

mg/L

baseline and 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Serum Creatinine

Posted

Mean

Standard Deviation

mg/dL

baseline and 48 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Serum Creatinine

Posted

Mean

Standard Deviation

mg/dL

baseline and 96 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Serum Creatinine

Posted

Mean

Standard Deviation

mg/dL

baseline and day 7

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Serum Creatinine

Posted

Mean

Standard Deviation

mg/dL

baseline and day 60

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Patient Well Being, as Determined by a Visual Analog Scale

Global Visual Analog Scale Scale Range 0-2400; higher score is better

Posted

Mean

Standard Deviation

units on a scale

Measured at 24 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Patient Well Being, as Determined by a Visual Analog Scale

Global Visual Analog Scale Scale Range 0-4800; higher score is better

Posted

Mean

Standard Deviation

units on a scale

48 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Dyspnea VAS

Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better

Posted

Mean

Standard Deviation

units on a scale

48 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Dyspnea VAS

Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better

Posted

Mean

Standard Deviation

units on a scale

72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Cystatin C

Posted

Mean

Standard Deviation

mg/L

baseline and day 7

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Cystatin C

Posted

Mean

Standard Deviation

mg/L

baseline and day 60

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Uric Acid

Posted

Mean

Standard Deviation

mg/dL

baseline and 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Uric Acid

Posted

Mean

Standard Deviation

mg/dL

baseline and day 7

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in Uric Acid

Posted

Mean

Standard Deviation

mg/dL

baseline and Day 60

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in B-type Natriuretic Peptide

Change in NTproBNP

Posted

Mean

Standard Deviation

pg/mL

baseline and 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in NTproBNP

Posted

Mean

Standard Deviation

pg/mL

baseline and Day 7

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Change in NTproBNP

Posted

Mean

Standard Deviation

pg/mL

baseline and Day 60

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Presence of Cardiorenal Syndrome

Posted

Number

percentage of participants

Within 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

percentage of participants

Within 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants

Secondary

Net Fluid Loss

Posted

Mean

Standard Deviation

Through 24 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Net Fluid Loss

Posted

Mean

Standard Deviation

Through 48 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Secondary

Net Fluid Loss

Posted

Mean

Standard Deviation

Through 72 hours

ID	Title	Description
OG000	Q 12 Hour Bolus
OG001	Continuous Infusion
OG002	Low Intensification
OG003	High Intensification

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)
EG000	Q 12 Hour Bolus	69	156
EG001	Continuous Infusion	67	152
EG002	Low Intensification	76	151
EG003	High Intensification	60	157

Serious Adverse Events

Term	Organ System	Statistical Information
Cardiac Failure	Cardiac disorders	EG00017 affected156 at risk EG00118 affected152 at risk EG00220 affected151 at risk EG00315 affected157 at risk
Cardiac Failure Acute	Cardiac disorders	EG00013 affected156 at risk EG0016 affected152 at risk EG0029 affected151 at risk EG003
Ventricular Tachycardia	Cardiac disorders	EG0007 affected156 at risk EG0014 affected152 at risk EG0027 affected151 at risk EG003
Renal Failure	Renal and urinary disorders	EG0005 affected156 at risk EG0016 affected152 at risk EG0027 affected151 at risk EG003
Hypotension	Vascular disorders	EG0007 affected156 at risk EG0019 affected152 at risk EG00211 affected151 at risk EG003
Anemia	Blood and lymphatic system disorders	EG0003 affected156 at risk EG0010 affected152 at risk EG0022 affected151 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	EG0004 affected156 at risk EG0011 affected152 at risk EG0024 affected151 at risk EG003
Cardiac Arrest	Cardiac disorders	EG0003 affected156 at risk EG0013 affected152 at risk EG0023 affected151 at risk EG003
Sepsis	Infections and infestations	EG0003 affected156 at risk EG0014 affected152 at risk EG0025 affected151 at risk EG003
Renal Failure Acute	Renal and urinary disorders	EG0003 affected156 at risk EG0015 affected152 at risk EG0026 affected151 at risk EG003
Angina Pectoris	Cardiac disorders	EG0002 affected156 at risk EG0011 affected152 at risk EG0022 affected151 at risk EG003
Atrial Fibrillation	Cardiac disorders	EG0001 affected156 at risk EG0012 affected152 at risk EG0022 affected151 at risk EG003
Atrial Tachycardia	Cardiac disorders	EG0001 affected156 at risk EG0011 affected152 at risk EG0021 affected151 at risk EG003
Cardiac Failure Chronic	Cardiac disorders	EG0001 affected156 at risk EG0013 affected152 at risk EG0022 affected151 at risk EG003
Cardiogenic Shock	Cardiac disorders	EG0001 affected156 at risk EG0010 affected152 at risk EG0021 affected151 at risk EG003
Myocardial Infarction	Cardiac disorders	EG0001 affected156 at risk EG0010 affected152 at risk EG0020 affected151 at risk EG003
Ventricular Arrhythmia	Cardiac disorders	EG0001 affected156 at risk EG0011 affected152 at risk EG0022 affected151 at risk EG003
Arterial Thrombosis Limb	Vascular disorders	EG0001 affected156 at risk EG0010 affected152 at risk EG0021 affected151 at risk EG003
Deep Vein Thrombosis	Vascular disorders	EG0001 affected156 at risk EG0010 affected152 at risk EG0021 affected151 at risk EG003
Shock Haemorrhagic	Vascular disorders	EG0000 affected156 at risk EG0011 affected152 at risk EG0021 affected151 at risk EG003
Renal Failure Chronic	Renal and urinary disorders	EG0000 affected156 at risk EG0011 affected152 at risk EG0020 affected151 at risk EG003
Cerebrovascular Accident	Nervous system disorders	EG0002 affected156 at risk EG0012 affected152 at risk EG0023 affected151 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	EG0002 affected156 at risk EG0016 affected152 at risk EG0023 affected151 at risk EG003

ID	Term
D006333	Heart Failure
D004487	Edema

ID	Term
D049994	Sodium Potassium Chloride Symporter Inhibitors

Ancestor Terms

ID	Term
D049990	Membrane Transport Modulators
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D004232	Diuretics
D045283	Natriuretic Agents
D045505	Physiological Effects of Drugs

OG000155
OG001147
OG002147
OG003155

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms