Combination Diuretic Therapy for Acute Decompensated Heart Failure
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Registration Number
- NCT05840536
- Lead Sponsor
- Ochsner Health System
- Brief Summary
Patients with heart failure are often admitted to the hospital because they have accumulated excessive amounts of fluid, they become short of breath and congested with fluid. Removing the excess fluid is necessary to improve the patients symptoms and reduce the risk of being re-admitted to the hospital. Diuretics ("water pills") are often given through an IV to accelerate the fluid removal. Furosemide is commonly used for fluid removal, however some patients do not respond well to the medication. There are other diuretics available that can work in conjunction with furosemide and increase the rate of fluid removal. The other "water pills" have slightly different mechanisms of action in the body compared to furosemide and when combined they may increase fluid removal.
The investigators hypothesize that adding chlorothiazide to furosemide will result in quicker and more effective fluid removal in heart failure patients.
- Detailed Description
The investigators will randomly assign patients to receive either furosemide alone or furosemide in combination with chlorothiazide when they are admitted to the hospital with acute heart failure and excessive volume.
All patients will be monitored for rate of fluid removal, improvement in symptoms, and side-effects of the medications.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Diagnosis of Acute Decompensated Heart Failure - by at least 1 symptom (dyspnea, exercise intolerance, weight gain, edema) and at least 1 sign (chest x-ray (CXR), elevated brain natriuretic peptide (BNP), rales, elevated jugular venous pressure (JVP)).
- History of Congestion Heart Failure (CHF) with chronic loop diuretic use for at least the past 4 weeks
- Echocardiogram in the past 12 months (to document Ejection fraction (EF))
- Chronic Kidney Disease (CKD) or Acute Kidney Injury (AKI) - Cr >2.5 mg/dL
- Ventricular assist device
- Cardiogenic shock
- Need for mechanical or vasopressor support on admission
- Significant co-morbidities: Chronic Obstructive Pulmonary Disease, pneumonia, pulmonary embolism
- History of pulmonary hypertension (PAH) (World Health Organization (WHO) group I primary PAH)
- Acute Ischemia / post-intervention (Coronary Artery Bypass Graft, Percutaneous Coronary Interventions) in the past 90 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Diuretic Therapy Furosemide plus Chlorothiazide Patients will receive lasix infusion starting at 5mg/hr along with a bolus dose of chlorothiazide 250mg at the initiation of the protocol. The lasix infusion can be titrated to 10mg after 12hrs based on volume of diuresis. This arm will also receive 250mg bolus doses of chlorothiazide every 12hrs for the duration of the study. Monotherapy Diuretic Furosemide Patients will receive furosemide infusion at 5mg/hr along with an initial bolus dose of furosemide equal to twice their home oral dose. The furosemide infusion can be increased to 10mg/hr after 12hrs based on urine output. This arm will receive bolus doses of furosemide every 12hrs equal to twice their home oral dose until completion of the protocol. Combination Diuretic Therapy Furosemide Patients will receive lasix infusion starting at 5mg/hr along with a bolus dose of chlorothiazide 250mg at the initiation of the protocol. The lasix infusion can be titrated to 10mg after 12hrs based on volume of diuresis. This arm will also receive 250mg bolus doses of chlorothiazide every 12hrs for the duration of the study.
- Primary Outcome Measures
Name Time Method Change in Serum Creatinine from Baseline During Index Admission up to 120 hours Change in serum creatinine from baseline after 72 hours of diuresis
Volume of Diuresis During Index Hospitalization at 72 hours Total volume of urine output will be collected during the first 72 hours of admission.
- Secondary Outcome Measures
Name Time Method Relief of Symptoms From date of index hospitalization until 72 hours after diuresis Using the five-point Likert scale for dyspnea which ranges from 1-5 where the lower the score the better the outcome
Length of Stay From date of index hospitalization until date of discharge from hospital, assessed up to 1 week Electrolyte Disturbances From date of index hospitalization until 72 hours after diuresis Magnesium, Phosphorous
Hypokalemia From date of index hospitalization until 72 hours after diuresis Total Weight Loss From date of index hospitalization until 72 hours after diuresis Potassium Replacement Requirements From date of index hospitalization until date of discharge from hospital, assessed up to 1 week Adverse Events From date of index hospitalization until date of discharge from hospital, assessed up to 1 week Hypotension, dizziness, syncope, acute renal failure, arrhythmia
Trial Locations
- Locations (1)
Ochsner Heart and Vascular Institute
🇺🇸New Orleans, Louisiana, United States