Acute Decompensated Heart Failure
Conditions
Keywords
Acute Decompensated Heart Failure, Diuretics
Brief summary
The purpose of this prospective, randomized, open-label study is to compare two diuretic strategies in patients with acute decompensated heart failure (ADHF): the addition of an oral thiazide diuretic to intravenous bolus (IVB) loop diuretic will be compared to transition from IVB to continuous infusion (CI) loop diuretic.
Detailed description
Patients hospitalized for ADHF secondary to fluid overload and who are experiencing an inadequate response to IVB furosemide and require additional diuresis will be enrolled. Patients will be randomized to one of two treatment arms: the addition of oral metolazone to continued IVB furosemide versus transition from IVB to CI furosemide. A suggested algorithm for initial dosing and titration of these two diuretic strategies will be provided. Baseline and daily data collection will include various efficacy and safety endpoints including daily net urine output and weight, patient and physician global assessment scale, length of stay, 30-day death or rehospitalization, vital signs, electrolytes, and renal function. Clinically meaningful efficacy and safety endpoints will be compared.
Interventions
DRUGAddition of oral Metolazone
Addition of oral metolazone 5 mg daily to continued current dose of intravenous bolus furosemide
DRUGFurosemide dose escalation
Furosemide dose escalation via either IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours)
Sponsors
University of Illinois at Chicago
Virginia Commonwealth University
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Greater than or equal to 18 years of age 2. Hospitalized for acute decompensated heart failure (ADHF) secondary to fluid overload as defined by the presence of at least * 1 symptom (e.g. dyspnea, orthopnea, paroxysmal nocturnal dyspnea) AND * 1 sign (e.g. rales on auscultation, \> 2+ peripheral or presacral\> edema, hepatomegaly, ascites, jugular vein distension \> 7 cm, pulmonary vascular congestion on chest radiography) 3. Inadequate response to IV diuretics and requiring additional diuresis as determined by primary medical team 4. Received less than six doses of IV furosemide OR enrolled within 72 hours of hospital admission 5. Anticipated need for intravenous diuretic therapy for at least 48 hours 6. Able to provide informed consent
Exclusion criteria
1. Receiving a continuous infusion loop diuretic during current hospital visit 2. Substantial diuretic response to pre-randomization diuretic dosing such that higher doses of diuretic would be contraindicated (based on judgement of patient's primary team) 3. Planned or ongoing intravenous vasoactive therapy (e.g. inotrope, vasodilator) or mechanical support (e.g. intra-aortic balloon pump, ventricular assist device) for ADHF during this hospitalization 4. Planned elective admission for elective placement/revision of a cardiovascular device (e.g. defibrillator, biventricular pacemaker) during this hospitalization or such within the preceding 7 days 5. Systolic blood pressure \< 90 mmHg 6. Serum creatinine \> 3 mg/dL at baseline or renal replacement therapy including ultrafiltration 7. Serum potassium \< 3.5 mEq/L (3.0 - 3.4 mEq/L allowed if supplemental potassium is being administered) 8. Serum magnesium \< 1.6 mg/dL (1.4 - 1.5 mg/dL allowed if supplemental magnesium is being administered) 9. Acute coronary syndrome or hemodynamically significant arrhythmias causing worsening HF 10. Severe, uncorrected primary cardiac valvular disease, acute myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, restrictive or constrictive cardiomyopathy, complex congenital heart disease 11. Primary pulmonary hypertension with right sided heart failure 12. Use of iodinated radiocontrast material in prior 72 hours or planned within the next 48 hours 13. Enrollment or planned enrollment in another randomized clinical trial during hospitalization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization) | 24-48 hours | Net fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Weight | Baseline (Dry), Baseline, 0-24, 24-48, 48-72, 72-96 hrs | — |
| Daily Net Fluid Output on Days 1, 3, and 4 | 0-24, 48-72, 72-96 hrs | Daily net fluid output = daily fluid output - daily intake. A negative value means that daily fluid intake was less than the daily fluid output. |
| Patient Global Assessment Scale | Baseline, 24, 48, 72, 96 hrs | Scale range: 1-5 Which of the following best describes your overall health state today? 1. = markedly worse 2. = worse 3. = neither better nor worse 4. = better 5. = markedly better |
| Physician Global Assessment Scale | Baseline, 24, 48, 72, 96 hours | Scale range: 1-5 Which of the following best describes the patient's overall health state today? 1. = markedly worse 2. = worse 3. = neither better nor worse 4. = better 5. = markedly better |
| Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure) | 0-96 hours | Patients will be considered a treatment failure if they require additional diuretic (including crossover to the alternative study arm) or require IV vasoactive drug therapy (e.g. vasodilators including nitroglycerin or inotropes) as deemed appropriate/necessary by their medical team. |
| Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 0-24, 24-48, 48-72, 72-96 hrs | — |
| Length of Hospitalization | Assessed till hospital discharge, an average of 1 week (longest 29 days) | — |
| 30-day All-cause Mortality | 30 days | — |
| Rehospitalization at 30 Days | 30 days | — |
| Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic | 30 days | — |
| Blood Urea Nitrogen (BUN) | Baseline, 24, 48, 72, 96 hours | — |
| Time to Return to Baseline Weight | 0-96 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Furosemide Dose Escalation IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours) | 5 |
| IVB Loop and PO Thiazide Diuretic Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose) | 6 |
| Total | 11 |
Baseline characteristics
| Characteristic | Furosemide Dose Escalation | Total | IVB Loop and PO Thiazide Diuretic |
|---|---|---|---|
| Afib on Admission Absent | 3 Participants | 8 Participants | 5 Participants |
| Afib on Admission Not reported | 2 Participants | 3 Participants | 1 Participants |
| Afib on Admission Present | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 57.6 years STANDARD_DEVIATION 16 | 56.6 years STANDARD_DEVIATION 15.3 | 55.8 years STANDARD_DEVIATION 16.2 |
| Baseline Ejection Fraction (EF) (%) Mild (55-60%) | 2 Participants | 3 Participants | 1 Participants |
| Baseline Ejection Fraction (EF) (%) Moderate (20-40%) | 1 Participants | 6 Participants | 5 Participants |
| Baseline Ejection Fraction (EF) (%) Severe (5-15%) | 2 Participants | 2 Participants | 0 Participants |
| Brain Natriuretic Peptide (BNP) at admission | 6800.75 pg/ml STANDARD_DEVIATION 10330.95 | 6201.00 pg/ml STANDARD_DEVIATION 7313.54 | 5401.33 pg/ml STANDARD_DEVIATION 4183.06 |
| Chief Complaints Fluid Overload | 1 participants | 2 participants | 2 participants |
| Chief Complaints Shortness of Breath (SOB) | 2 participants | 3 participants | 2 participants |
| Chief Complaints Weight Gain | 0 participants | 1 participants | 1 participants |
| Comorbidities Anemia | 2 participants | 2 participants | 0 participants |
| Comorbidities Cerebrovascular accident (CVA) | 1 participants | 3 participants | 2 participants |
| Comorbidities Chronic obstructive pulmonary disease (COPD) | 0 participants | 2 participants | 2 participants |
| Comorbidities Coronary artery disease (CAD) | 1 participants | 4 participants | 3 participants |
| Comorbidities Diabetes | 4 participants | 7 participants | 3 participants |
| Comorbidities Dyslipidemia | 4 participants | 6 participants | 2 participants |
| Comorbidities Gastroesophageal reflux disease (GERD) | 1 participants | 1 participants | 0 participants |
| Comorbidities Gout | 1 participants | 2 participants | 1 participants |
| Comorbidities Human immunodeficiency virus (HIV) | 1 participants | 1 participants | 0 participants |
| Comorbidities Hypertension | 4 participants | 8 participants | 4 participants |
| Comorbidities Myocardial infarction (MI) | 1 participants | 2 participants | 1 participants |
| Comorbidities Obesity | 2 participants | 3 participants | 1 participants |
| Comorbidities Obstructive Sleep Apnea | 2 participants | 4 participants | 2 participants |
| Medication Aldosterone Antagonist | 0 participants | 1 participants | 1 participants |
| Medication Angiotensin-converting-enzyme inhibitor | 4 participants | 10 participants | 6 participants |
| Medication Angiotensin Receptor Blockers | 0 participants | 0 participants | 0 participants |
| Medication Anticoagulant | 2 participants | 5 participants | 3 participants |
| Medication Aspirin | 2 participants | 7 participants | 5 participants |
| Medication Beta Blocker | 4 participants | 8 participants | 4 participants |
| Medication Calcium Channel Blocker | 2 participants | 3 participants | 1 participants |
| Medication Digoxin | 2 participants | 2 participants | 0 participants |
| Medication Hydralazine | 4 participants | 5 participants | 1 participants |
| Medication Isosorbide Dinitrate | 1 participants | 2 participants | 1 participants |
| Medication Loop Diuretic | 4 participants | 9 participants | 5 participants |
| Medication Potassium supplement | 1 participants | 4 participants | 3 participants |
| Medication Statin | 5 participants | 9 participants | 4 participants |
| New York Heart Association (NYHA) Class on Admission Class I | 0 Participants | 0 Participants | 0 Participants |
| New York Heart Association (NYHA) Class on Admission Class II | 0 Participants | 0 Participants | 0 Participants |
| New York Heart Association (NYHA) Class on Admission Class III | 0 Participants | 3 Participants | 3 Participants |
| New York Heart Association (NYHA) Class on Admission Class IV | 1 Participants | 2 Participants | 1 Participants |
| New York Heart Association (NYHA) Class on Admission Not Reported | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 2 / 5 | 6 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization)
Net fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output.
Time frame: 24-48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Furosemide Dose Escalation | Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization) | -1454.60 mL/day | Standard Deviation 1339.53 |
| IVB Loop and PO Thiazide Diuretic | Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization) | -1322.83 mL/day | Standard Deviation 1738.3 |
Secondary
30-day All-cause Mortality
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide Dose Escalation | 30-day All-cause Mortality | 0 Participants |
| IVB Loop and PO Thiazide Diuretic | 30-day All-cause Mortality | 0 Participants |
Secondary
Blood Urea Nitrogen (BUN)
Time frame: Baseline, 24, 48, 72, 96 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furosemide Dose Escalation | Blood Urea Nitrogen (BUN) | 24 hr | 28.00 mg/dL | Standard Deviation 9.35 |
| Furosemide Dose Escalation | Blood Urea Nitrogen (BUN) | 72 hr | 29.00 mg/dL | Standard Deviation 12.08 |
| Furosemide Dose Escalation | Blood Urea Nitrogen (BUN) | 48 hr | 30.80 mg/dL | Standard Deviation 11.45 |
| Furosemide Dose Escalation | Blood Urea Nitrogen (BUN) | 96 hr | 38.60 mg/dL | Standard Deviation 19.63 |
| Furosemide Dose Escalation | Blood Urea Nitrogen (BUN) | Baseline | 31.20 mg/dL | Standard Deviation 11.05 |
| IVB Loop and PO Thiazide Diuretic | Blood Urea Nitrogen (BUN) | 96 hr | 42.67 mg/dL | Standard Deviation 20.63 |
| IVB Loop and PO Thiazide Diuretic | Blood Urea Nitrogen (BUN) | Baseline | 29.83 mg/dL | Standard Deviation 16.82 |
| IVB Loop and PO Thiazide Diuretic | Blood Urea Nitrogen (BUN) | 24 hr | 27.67 mg/dL | Standard Deviation 17.18 |
| IVB Loop and PO Thiazide Diuretic | Blood Urea Nitrogen (BUN) | 48 hr | 33.17 mg/dL | Standard Deviation 16.92 |
| IVB Loop and PO Thiazide Diuretic | Blood Urea Nitrogen (BUN) | 72 hr | 42.00 mg/dL | Standard Deviation 20.7 |
Secondary
Daily Net Fluid Output on Days 1, 3, and 4
Daily net fluid output = daily fluid output - daily intake. A negative value means that daily fluid intake was less than the daily fluid output.
Time frame: 0-24, 48-72, 72-96 hrs
Population: If diuretic therapy is changed to the oral route before a scheduled efficacy endpoint is to be measured (e.g.72 or 96 hour net output), then that endpoint will not be obtained.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furosemide Dose Escalation | Daily Net Fluid Output on Days 1, 3, and 4 | 0-24 hr | -2226.74 ml/day | Standard Deviation 2063.63 |
| Furosemide Dose Escalation | Daily Net Fluid Output on Days 1, 3, and 4 | 48-72 hr | -2108.00 ml/day | Standard Deviation 2187.05 |
| Furosemide Dose Escalation | Daily Net Fluid Output on Days 1, 3, and 4 | 72-96 hr | -2433.33 ml/day | Standard Deviation 1374.38 |
| IVB Loop and PO Thiazide Diuretic | Daily Net Fluid Output on Days 1, 3, and 4 | 0-24 hr | -3076.67 ml/day | Standard Deviation 1555.63 |
| IVB Loop and PO Thiazide Diuretic | Daily Net Fluid Output on Days 1, 3, and 4 | 48-72 hr | -409.74 ml/day | Standard Deviation 1208.98 |
| IVB Loop and PO Thiazide Diuretic | Daily Net Fluid Output on Days 1, 3, and 4 | 72-96 hr | -705.33 ml/day | Standard Deviation 157.39 |
Secondary
Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)
Time frame: 0-24, 24-48, 48-72, 72-96 hrs
Population: Data were not collected at all time points for all subjects, and were only analyzed when available. Data not analyzed on days when diuretics were held or discontinued.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furosemide Dose Escalation | Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 24-48 hr | 8.28 ml/mg furosemide received | Standard Deviation 4.59 |
| Furosemide Dose Escalation | Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 0-24 hr | 29.35 ml/mg furosemide received | Standard Deviation 21.01 |
| Furosemide Dose Escalation | Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 72-96 hr | 43.94 ml/mg furosemide received | Standard Deviation 28.12 |
| Furosemide Dose Escalation | Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 48-72 hr | 25.84 ml/mg furosemide received | Standard Deviation 20.05 |
| IVB Loop and PO Thiazide Diuretic | Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 24-48 hr | 21.88 ml/mg furosemide received | Standard Deviation 14.39 |
| IVB Loop and PO Thiazide Diuretic | Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 0-24 hr | 17.35 ml/mg furosemide received | Standard Deviation 7.11 |
| IVB Loop and PO Thiazide Diuretic | Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received) | 48-72 hr | 25.52 ml/mg furosemide received | Standard Deviation 14.84 |
Secondary
Daily Weight
Time frame: Baseline (Dry), Baseline, 0-24, 24-48, 48-72, 72-96 hrs
Population: Data were not collected for all subjects at all time points, and were only analyzed when available
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furosemide Dose Escalation | Daily Weight | Baseline (Dry) | 82.35 Kg | Standard Deviation 40.87 |
| Furosemide Dose Escalation | Daily Weight | Baseline | 120.84 Kg | Standard Deviation 75.25 |
| Furosemide Dose Escalation | Daily Weight | 0-24 hr | 154.23 Kg | Standard Deviation 103.3 |
| Furosemide Dose Escalation | Daily Weight | 24-48 hr | 129.73 Kg | Standard Deviation 91.46 |
| Furosemide Dose Escalation | Daily Weight | 48-72 hr | 135.07 Kg | Standard Deviation 101.31 |
| Furosemide Dose Escalation | Daily Weight | 72-96 hr | 172.10 Kg | Standard Deviation 107.71 |
| IVB Loop and PO Thiazide Diuretic | Daily Weight | 48-72 hr | 106.70 Kg | Standard Deviation 52.18 |
| IVB Loop and PO Thiazide Diuretic | Daily Weight | Baseline (Dry) | 100.82 Kg | Standard Deviation 49.35 |
| IVB Loop and PO Thiazide Diuretic | Daily Weight | 24-48 hr | 99.08 Kg | Standard Deviation 32.93 |
| IVB Loop and PO Thiazide Diuretic | Daily Weight | Baseline | 102.57 Kg | Standard Deviation 33.57 |
| IVB Loop and PO Thiazide Diuretic | Daily Weight | 72-96 hr | 86.87 Kg | Standard Deviation 48.17 |
| IVB Loop and PO Thiazide Diuretic | Daily Weight | 0-24 hr | 101.07 Kg | Standard Deviation 32.88 |
Secondary
Length of Hospitalization
Time frame: Assessed till hospital discharge, an average of 1 week (longest 29 days)
Population: Data not available in all subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Furosemide Dose Escalation | Length of Hospitalization | 4.75 Days | Standard Deviation 1.71 |
| IVB Loop and PO Thiazide Diuretic | Length of Hospitalization | 11.25 Days | Standard Deviation 10.93 |
Secondary
Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure)
Patients will be considered a treatment failure if they require additional diuretic (including crossover to the alternative study arm) or require IV vasoactive drug therapy (e.g. vasodilators including nitroglycerin or inotropes) as deemed appropriate/necessary by their medical team.
Time frame: 0-96 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide Dose Escalation | Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure) | 1 Participants |
| IVB Loop and PO Thiazide Diuretic | Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure) | 4 Participants |
Secondary
Patient Global Assessment Scale
Scale range: 1-5 Which of the following best describes your overall health state today? 1. = markedly worse 2. = worse 3. = neither better nor worse 4. = better 5. = markedly better
Time frame: Baseline, 24, 48, 72, 96 hrs
Population: Data were not collected at all time points, and were only analyzed when available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furosemide Dose Escalation | Patient Global Assessment Scale | 24 hr | 4.2 units on a scale | Standard Deviation 0.45 |
| Furosemide Dose Escalation | Patient Global Assessment Scale | 72 hr | 4.67 units on a scale | Standard Deviation 2.59 |
| Furosemide Dose Escalation | Patient Global Assessment Scale | 48 hr | 3.8 units on a scale | Standard Deviation 1.1 |
| Furosemide Dose Escalation | Patient Global Assessment Scale | 96 hr | 4 units on a scale | Standard Deviation 2.19 |
| Furosemide Dose Escalation | Patient Global Assessment Scale | Baseline | 3.25 units on a scale | Standard Deviation 1.67 |
| IVB Loop and PO Thiazide Diuretic | Patient Global Assessment Scale | 96 hr | 4 units on a scale | Standard Deviation 2.19 |
| IVB Loop and PO Thiazide Diuretic | Patient Global Assessment Scale | Baseline | 3.67 units on a scale | Standard Deviation 2.23 |
| IVB Loop and PO Thiazide Diuretic | Patient Global Assessment Scale | 24 hr | 4.25 units on a scale | Standard Deviation 2.23 |
| IVB Loop and PO Thiazide Diuretic | Patient Global Assessment Scale | 48 hr | 3.6 units on a scale | Standard Deviation 1.67 |
| IVB Loop and PO Thiazide Diuretic | Patient Global Assessment Scale | 72 hr | 3.75 units on a scale | Standard Deviation 1.97 |
Secondary
Physician Global Assessment Scale
Scale range: 1-5 Which of the following best describes the patient's overall health state today? 1. = markedly worse 2. = worse 3. = neither better nor worse 4. = better 5. = markedly better
Time frame: Baseline, 24, 48, 72, 96 hours
Population: Data were not collected at all time points, and were only analyzed when available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Furosemide Dose Escalation | Physician Global Assessment Scale | 24 hr | 4.25 units on a scale | Standard Deviation 1.95 |
| Furosemide Dose Escalation | Physician Global Assessment Scale | 72 hr | 4.5 units on a scale | Standard Deviation 2.49 |
| Furosemide Dose Escalation | Physician Global Assessment Scale | 48 hr | 4 units on a scale | Standard Deviation 1.92 |
| Furosemide Dose Escalation | Physician Global Assessment Scale | 96 hr | 4 units on a scale | Standard Deviation 2.19 |
| Furosemide Dose Escalation | Physician Global Assessment Scale | Baseline | 2.67 units on a scale | Standard Deviation 1.67 |
| IVB Loop and PO Thiazide Diuretic | Physician Global Assessment Scale | 96 hr | 3.67 units on a scale | Standard Deviation 2.19 |
| IVB Loop and PO Thiazide Diuretic | Physician Global Assessment Scale | Baseline | 2 units on a scale | Standard Deviation 1.21 |
| IVB Loop and PO Thiazide Diuretic | Physician Global Assessment Scale | 24 hr | 4 units on a scale | Standard Deviation 2.16 |
| IVB Loop and PO Thiazide Diuretic | Physician Global Assessment Scale | 48 hr | 4 units on a scale | Standard Deviation 1.63 |
| IVB Loop and PO Thiazide Diuretic | Physician Global Assessment Scale | 72 hr | 3.75 units on a scale | Standard Deviation 1.97 |
Secondary
Rehospitalization at 30 Days
Time frame: 30 days
Population: 30-day follow up data (except for mortality) were not collected in 2 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide Dose Escalation | Rehospitalization at 30 Days | 1 Participants |
| IVB Loop and PO Thiazide Diuretic | Rehospitalization at 30 Days | 1 Participants |
Secondary
Time to Return to Baseline Weight
Time frame: 0-96 hours
Population: Weight was not collected in all subjects every day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Furosemide Dose Escalation | Time to Return to Baseline Weight | 1.5 Days | Standard Deviation 1.1 |
| IVB Loop and PO Thiazide Diuretic | Time to Return to Baseline Weight | 1.5 Days | Standard Deviation 0.84 |
Secondary
Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic
Time frame: 30 days
Population: 30-day follow up data (except for mortality) were not collected in 2 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Furosemide Dose Escalation | Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic | 1 Participants |
| IVB Loop and PO Thiazide Diuretic | Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic | 1 Participants |