Back to resultsCombination Diuretic Therapy for Acute Decompensated Heart Failure (COMBIND-HF)
Primary Purpose
Acute Decompensated Heart Failure
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Furosemide plus Chlorothiazide
Furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring heart failure, acute, diuretic, management, renal function, chlorothiazide, furosemide
Eligibility Criteria
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
Sites / Locations
- Ochsner Heart and Vascular Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combination Diuretic Therapy
Monotherapy Diuretic
Arm 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.
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.
Outcomes
Primary Outcome Measures
Volume of Diuresis
Total volume of urine output will be collected during the first 72 hours of admission.
Change in Serum Creatinine from Baseline
Change in serum creatinine from baseline after 72 hours of diuresis
Secondary Outcome Measures
Hypokalemia
Electrolyte Disturbances
Magnesium, Phosphorous
Total Weight Loss
Relief of Symptoms
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
Potassium Replacement Requirements
Adverse Events
Hypotension, dizziness, syncope, acute renal failure, arrhythmia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05840536
Brief Title
Combination Diuretic Therapy for Acute Decompensated Heart Failure
Acronym
COMBIND-HF
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 Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ochsner Health System
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
heart failure, acute, diuretic, management, renal function, chlorothiazide, furosemide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination Diuretic Therapy
Arm Type
Experimental
Arm 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.
Arm Title
Monotherapy Diuretic
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Furosemide plus Chlorothiazide
Other Intervention Name(s)
Lasix plus Diuril
Intervention 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.
Intravenous (IV) lasix infusion at 5mg/hr plus IV boluses of diuril every 12 hrs.
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
Lasix
Intervention 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.
Primary Outcome Measure Information:
Title
Volume of Diuresis
Description
Total volume of urine output will be collected during the first 72 hours of admission.
Time Frame
During Index Hospitalization at 72 hours
Title
Change in Serum Creatinine from Baseline
Description
Change in serum creatinine from baseline after 72 hours of diuresis
Time Frame
During Index Admission up to 120 hours
Secondary Outcome Measure Information:
Title
Hypokalemia
Time Frame
From date of index hospitalization until 72 hours after diuresis
Title
Electrolyte Disturbances
Description
Magnesium, Phosphorous
Time Frame
From date of index hospitalization until 72 hours after diuresis
Title
Total Weight Loss
Time Frame
From date of index hospitalization until 72 hours after diuresis
Title
Relief of Symptoms
Description
Using the five-point Likert scale for dyspnea which ranges from 1-5 where the lower the score the better the outcome
Time Frame
From date of index hospitalization until 72 hours after diuresis
Title
Length of Stay
Time Frame
From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
Title
Potassium Replacement Requirements
Time Frame
From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
Title
Adverse Events
Description
Hypotension, dizziness, syncope, acute renal failure, arrhythmia
Time Frame
From date of index hospitalization until date of discharge from hospital, assessed up to 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick T Campbell, MD
Organizational Affiliation
Ochsner Heart and Vascular Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stacy Mandras, MD
Organizational Affiliation
Ochsner Heart and Vascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Heart and Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21366472
Citation
Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
Results Reference
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PubMed Identifier
8130022
Citation
Channer KS, McLean KA, Lawson-Matthew P, Richardson M. Combination diuretic treatment in severe heart failure: a randomised controlled trial. Br Heart J. 1994 Feb;71(2):146-50. doi: 10.1136/hrt.71.2.146.
Results Reference
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PubMed Identifier
18931492
Citation
Peacock WF, Costanzo MR, De Marco T, Lopatin M, Wynne J, Mills RM, Emerman CL; ADHERE Scientific Advisory Committee and Investigators. Impact of intravenous loop diuretics on outcomes of patients hospitalized with acute decompensated heart failure: insights from the ADHERE registry. Cardiology. 2009;113(1):12-9. doi: 10.1159/000164149. Epub 2008 Oct 17.
Results Reference
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Combination Diuretic Therapy for Acute Decompensated Heart Failure
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