COMBIND-HF: Combination Diuretic Therapy for Acute Decompensated Heart Failure

Sponsor

Ochsner Health System (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05840536

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Decompensated Heart Failure	Drug: Furosemide plus Chlorothiazide Drug: Furosemide	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Tolerability of Combination Intravenous Diuretic Therapy Versus Intravenous Loop Diuretic Therapy Alone for the Treatment of Acute Decompensated Heart Failure

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2015

Anticipated Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination Diuretic Therapy 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.	Drug: 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. Intravenous (IV) lasix infusion at 5mg/hr plus IV boluses of diuril every 12 hrs. Other Names: Lasix plus Diuril Drug: 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. Other Names: Lasix
Active Comparator: Monotherapy Diuretic 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.	Drug: 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. Other Names: Lasix

Arm

Intervention/Treatment

Experimental: Combination Diuretic Therapy

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.

Drug: Furosemide plus Chlorothiazide

Other Names:

Lasix plus Diuril

Drug: 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.

Other Names:

Lasix

Active Comparator: Monotherapy Diuretic

Drug: Furosemide

Other Names:

Lasix

Outcome Measures

Primary Outcome Measures

Volume of Diuresis [During Index Hospitalization at 72 hours]
Total volume of urine output will be collected during the first 72 hours of admission.
Change in Serum Creatinine from Baseline [During Index Admission up to 120 hours]
Change in serum creatinine from baseline after 72 hours of diuresis

Secondary Outcome Measures

Hypokalemia [From date of index hospitalization until 72 hours after diuresis]
Electrolyte Disturbances [From date of index hospitalization until 72 hours after diuresis]
Magnesium, Phosphorous
Total Weight Loss [From date of index hospitalization until 72 hours after diuresis]
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]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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))

Exclusion Criteria:

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