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OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure (OUTLAST)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Furosemide
IV Solution
Sponsored by
New York Presbyterian Brooklyn Methodist Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, hospitalization, diuretics, IV diuretics, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients being admitted with ADHF over 18 years old
  • Known history of systolic or diastolic dysfunction of greater than 6 weeks
  • NYHA Class II-IV
  • Heart failure as defined in [Table 1]. One symptom must be present at time of screening and one sign must be present in the last 12 months
  • Elevated pro-BNP >/= 360 pg/ml and not explained by any other etiology
  • Willing to consent and comply with scheduled visits and phone calls

Table 1. Criteria for Diagnosing Heart Failure

SYMPTOMS (at least 1 must be present at time of screening):

  • Paroxysmal nocturnal dyspnea
  • Orthopnea
  • Dyspnea on mild or moderate exertion

SIGNS (at least 1 must be present in the last 12 months)

  • Any rales post cough
  • Jugular venous pressure >/= 10 cm H20
  • Lower extremity edema
  • Chest X-Ray (CXR) demonstrating pleural effusion, pulmonary congestion, or cardiomegaly

Exclusion Criteria:

  • Systolic blood pressure <85 mmHg
  • Signs of significant respiratory distress, according to the discretion of the investigator.
  • Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion
  • Chronic dialysis
  • Acute renal failure defined as creatinine > 2 x baseline
  • Severe systemic illness with life expectancy judged less than three years
  • Chronic pulmonary disease requiring home O2, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator
  • Primary hemodynamically significant uncorrected valvular heart disease, obstructive, or regurgitant, or any valvular disease expected to lead to surgery during the trial.
  • Atrial fibrillation with resting heart rate >90 bpm
  • Myocardial infarction in past 90 days
  • Percutaneous coronary intervention in past 30 days
  • Heart transplant recipient or currently implanted left ventricular assist device
  • Stroke in past 90 days
  • No acute infection especially requiring IV antibiotics
  • Allergy to Lasix
  • Known chronic hepatic disease, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal
  • Non-verbal patients, patients who cannot speak or understand English, patients with dementia and psychiatric illness, patients who are blind or deaf and patients who are transferred to different hospital will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Placebo Comparator

    Experimental

    Arm Label

    Standard of Care (Group 1)

    IV Placebo Infusion

    IV Furosemide Infusion

    Arm Description

    Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care.

    Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake.The infusions were continuous over 3 hours, biweekly over a one-month period.

    The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period.Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, SBP <80 mmHg or symptoms of presyncope).

    Outcomes

    Primary Outcome Measures

    Re-hospitalization for Heart Failure
    30-day rehospitalization for Heart Failure

    Secondary Outcome Measures

    Kansas City Cardiomyopathy Questionnaire(KCCQ) outcome measures
    Change in Quality of life will be quantified using KCCQ questionnaires
    Death, Myocardial Infarction, Stroke
    Occurrence of death, myocardial infarction, or stroke
    PHQ-2 outcome measures
    Change in depressive symptoms will be quantified using PHQ-2 questionnaire

    Full Information

    First Posted
    December 23, 2020
    Last Updated
    December 29, 2020
    Sponsor
    New York Presbyterian Brooklyn Methodist Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04691687
    Brief Title
    OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure
    Acronym
    OUTLAST
    Official Title
    OUTpatient Intravenous LASix Trial in Reducing Hospitalization for ADHF (OUTLAST)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2012 (Actual)
    Primary Completion Date
    December 22, 2017 (Actual)
    Study Completion Date
    December 22, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    New York Presbyterian Brooklyn Methodist Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Single-center, prospective double-blinded randomized control trial to evaluate the the feasibility, efficacy and safety of outpatient IV diuretic therapy in treatment of heart failure.
    Detailed Description
    Patients were randomized by a clinical pharmacist with the ratio of 1:1:1 into 3 groups: standard of care control arm (Group 1), IV placebo infusion (Group 2), and IV furosemide infusion (Group 3).Patients in Group 2 and 3 received a comprehensive Heart Failure (HF)-care protocol that included bi-weekly clinic visits for dose-adjusted IV-diuretics, medication adjustment and education. Patients, nurses and treating physicians were blinded to the randomization. Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care.8 Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake. Patients in Group 3 received IV furosemide calculated by the pharmacist to be equivalent or higher in dose compared to the patient's home oral dose. The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period. Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, Systolic Blood Pressure(SBP) <80 mmHg or symptoms of presyncope). Patients in both Groups 2 and 3 resumed all of their oral home medications for HF post infusion visits per standard of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    heart failure, hospitalization, diuretics, IV diuretics, mortality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    A single center prospective randomized double-blind controlled trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Subjects, nurses and treating physicians will be blinded to whether the subjects are receiving continuous IV furosemide (group 2) or continuous IV placebo (group 3). The pharmacist will not be blinded to help administer the appropriate medication. Because the trial will be double-blinded, safety laboratory tests will be performed for each subject for the duration of the trial, regardless of the treatment arm, and will be monitored by the research coordinator. Similarly, monitoring of potential side effects will be continuous and irrespective of treatment assignment. Outcomes assessor will be blinded.
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care (Group 1)
    Arm Type
    No Intervention
    Arm Description
    Patients in Group 1 received standard of care treatment per heart failure guidelines at the discretion of the primary cardiologist involved in the patient's care.
    Arm Title
    IV Placebo Infusion
    Arm Type
    Placebo Comparator
    Arm Description
    Patients in Group 2 received IV saline infusion (20-40 ml) concentrated by the pharmacist to minimize fluid intake.The infusions were continuous over 3 hours, biweekly over a one-month period.
    Arm Title
    IV Furosemide Infusion
    Arm Type
    Experimental
    Arm Description
    The dose assignments were categorized into low dose (20 mg bolus with 20 mg/hour infusion sessions and 2 ml saline), intermediate dose (40 mg bolus with 40 mg/hour infusion sessions and 4 ml saline) and high dose (80 mg bolus with 80 mg/hour infusion sessions). The infusions were continuous over 3 hours, biweekly over a one-month period.Infusions were held at the discretion of the physician utilizing a written protocol (creatinine 25% above baseline, SBP <80 mmHg or symptoms of presyncope).
    Intervention Type
    Drug
    Intervention Name(s)
    Furosemide
    Other Intervention Name(s)
    IV Furosemide
    Intervention Description
    IV loop diuretic therapy
    Intervention Type
    Drug
    Intervention Name(s)
    IV Solution
    Other Intervention Name(s)
    IV Normal Saline 0.9%
    Intervention Description
    IV Placebo comparator
    Primary Outcome Measure Information:
    Title
    Re-hospitalization for Heart Failure
    Description
    30-day rehospitalization for Heart Failure
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Kansas City Cardiomyopathy Questionnaire(KCCQ) outcome measures
    Description
    Change in Quality of life will be quantified using KCCQ questionnaires
    Time Frame
    Change from Baseline to 30 days
    Title
    Death, Myocardial Infarction, Stroke
    Description
    Occurrence of death, myocardial infarction, or stroke
    Time Frame
    30 days, 180 days
    Title
    PHQ-2 outcome measures
    Description
    Change in depressive symptoms will be quantified using PHQ-2 questionnaire
    Time Frame
    Change from Baseline to 30 days
    Other Pre-specified Outcome Measures:
    Title
    New York Heart Association (NYHA) Class
    Description
    Change in NYHA functional class
    Time Frame
    Baseline and 30 days
    Title
    LV function
    Description
    Echo will be performed to evaluate heart function
    Time Frame
    Baseline and 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients being admitted with ADHF over 18 years old Known history of systolic or diastolic dysfunction of greater than 6 weeks NYHA Class II-IV Heart failure as defined in [Table 1]. One symptom must be present at time of screening and one sign must be present in the last 12 months Elevated pro-BNP >/= 360 pg/ml and not explained by any other etiology Willing to consent and comply with scheduled visits and phone calls Table 1. Criteria for Diagnosing Heart Failure SYMPTOMS (at least 1 must be present at time of screening): Paroxysmal nocturnal dyspnea Orthopnea Dyspnea on mild or moderate exertion SIGNS (at least 1 must be present in the last 12 months) Any rales post cough Jugular venous pressure >/= 10 cm H20 Lower extremity edema Chest X-Ray (CXR) demonstrating pleural effusion, pulmonary congestion, or cardiomegaly Exclusion Criteria: Systolic blood pressure <85 mmHg Signs of significant respiratory distress, according to the discretion of the investigator. Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion Chronic dialysis Acute renal failure defined as creatinine > 2 x baseline Severe systemic illness with life expectancy judged less than three years Chronic pulmonary disease requiring home O2, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator Primary hemodynamically significant uncorrected valvular heart disease, obstructive, or regurgitant, or any valvular disease expected to lead to surgery during the trial. Atrial fibrillation with resting heart rate >90 bpm Myocardial infarction in past 90 days Percutaneous coronary intervention in past 30 days Heart transplant recipient or currently implanted left ventricular assist device Stroke in past 90 days No acute infection especially requiring IV antibiotics Allergy to Lasix Known chronic hepatic disease, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal Non-verbal patients, patients who cannot speak or understand English, patients with dementia and psychiatric illness, patients who are blind or deaf and patients who are transferred to different hospital will be excluded.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure

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