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

April 24, 2023 updated by: Ochsner Health System

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypokalemia
Time Frame: From date of index hospitalization until 72 hours after diuresis
From date of index hospitalization until 72 hours after diuresis
Electrolyte Disturbances
Time Frame: From date of index hospitalization until 72 hours after diuresis
Magnesium, Phosphorous
From date of index hospitalization until 72 hours after diuresis
Total Weight Loss
Time Frame: From date of index hospitalization until 72 hours after diuresis
From date of index hospitalization until 72 hours after diuresis
Relief of Symptoms
Time Frame: 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
From date of index hospitalization until 72 hours after diuresis
Length of Stay
Time Frame: From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
Potassium Replacement Requirements
Time Frame: From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
Adverse Events
Time Frame: From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
Hypotension, dizziness, syncope, acute renal failure, arrhythmia
From date of index hospitalization until date of discharge from hospital, assessed up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Study Director: Patrick T Campbell, MD, Ochsner Heart and Vascular Institute
  • Principal Investigator: Stacy Mandras, MD, Ochsner Heart and Vascular Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OchsnerHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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