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

Sponsor

New York Presbyterian Brooklyn Methodist Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04691687

Collaborator

(none)

100

Enrollment

Arms

67.7

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Furosemide Drug: IV Solution	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A single center prospective randomized double-blind controlled trialA single center prospective randomized double-blind controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

OUTpatient Intravenous LASix Trial in Reducing Hospitalization for ADHF (OUTLAST)

Actual Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Dec 22, 2017

Actual Study Completion Date :

Dec 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care (Group 1) 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.
Placebo Comparator: IV Placebo Infusion 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.	Drug: IV Solution IV Placebo comparator Other Names: IV Normal Saline 0.9%
Experimental: IV Furosemide Infusion 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).	Drug: Furosemide IV loop diuretic therapy Other Names: IV Furosemide

Arm

Intervention/Treatment

No Intervention: Standard of Care (Group 1)

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.

Placebo Comparator: IV Placebo Infusion

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.

Drug: IV Solution

IV Placebo comparator

Other Names:

IV Normal Saline 0.9%

Experimental: IV Furosemide Infusion

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).

Drug: Furosemide

IV loop diuretic therapy

Other Names:

IV Furosemide

Outcome Measures

Primary Outcome Measures

Re-hospitalization for Heart Failure [30 days]
30-day rehospitalization for Heart Failure

Secondary Outcome Measures

Kansas City Cardiomyopathy Questionnaire(KCCQ) outcome measures [Change from Baseline to 30 days]
Change in Quality of life will be quantified using KCCQ questionnaires
Death, Myocardial Infarction, Stroke [30 days, 180 days]
Occurrence of death, myocardial infarction, or stroke
PHQ-2 outcome measures [Change from Baseline to 30 days]
Change in depressive symptoms will be quantified using PHQ-2 questionnaire

Other Outcome Measures

New York Heart Association (NYHA) Class [Baseline and 30 days]
Change in NYHA functional class
LV function [Baseline and 30 days]
Echo will be performed to evaluate heart function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.