Status:
COMPLETED
OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure
Lead Sponsor:
New York Presbyterian Brooklyn Methodist Hospital
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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).Pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04691687
Start Date
May 1 2012
End Date
December 22 2017
Last Update
December 31 2020
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