Combination Diuretic Therapy for Acute Decompensated Heart Failure (COMBIND-HF)

Ochsner Health System

Status and phase: Withdrawn; Phase 4

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: Furosemide plus Chlorothiazide; Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT05840536

OchsnerHS

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Combination Diuretic Therapy

Experimental group

Description:

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.

Treatment:

Drug: Furosemide

Drug: Furosemide plus Chlorothiazide

Monotherapy Diuretic

Active Comparator group

Description:

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.

Treatment:

Drug: Furosemide