Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)
Launched by DUKE UNIVERSITY · Dec 18, 2007
Trial Information
Current as of May 28, 2025
Completed
Keywords
ClinConnect Summary
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Heart failure symptoms include shortness of breath, swelling, and fatigue. Standard treatment for the swelling associated with heart failure includes the use of diuretic medications, such as furosemide, which cause urination and the removal of excess fluids in the body. Although furosemide has been used to treat heart failure patients for many years, it is still unclear how much of the drug to use, and over what time period the drug should be given. This study will evalu...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Prior clinical diagnosis of heart failure that was treated with daily oral loop diuretics for at least 1 month
- • Current diagnosis of heart failure, as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
- • Daily oral dose of furosemide between 80 mg and 240 mg (or equivalent)
- • Identified within 24 hours of hospital admission
- • Current treatment plan includes IV loop diuretics for at least 48 hours
- Exclusion Criteria:
- • Brain natriuretic peptide (BNP) less than 250 mg/mL or N-terminal prohormone brain natriuretic peptide (NT-proBNP) less than 1000 mg/mL
- • Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
- • Treatment plan during current hospitalization includes IV vasoactive treatment or ultra-filtration for heart failure
- • Substantial diuretic response to pre-randomization diuretic dosing such that higher doses of diuretics would be medically inadvisable
- • Systolic blood pressure less than 90 mm Hg
- • Serum creatinine level greater than 3.0 mg/dL at baseline or currently undergoing renal replacement therapy
- • Hemodynamically significant arrhythmias
- • Acute coronary syndrome within 4 weeks prior to study entry
- • Active myocarditis
- • Hypertrophic obstructive cardiomyopathy
- • Severe stenotic valvular disease
- • Restrictive or constrictive cardiomyopathy
- • Complex congenital heart disease
- • Constrictive pericarditis
- • Non-cardiac pulmonary edema
- • Clinical evidence of digoxin toxicity
- • Need for mechanical hemodynamic support
- • Sepsis
- • Terminal illness (other than heart failure) with expected survival time of less than 1 year
- • History of adverse reaction to the study drugs
- • Use of IV iodinated radiocontrast material within 72 hours prior to study entry or planned during hospitalization
- • Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
- • Inability to comply with planned study procedures
About Duke University
Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Houston, Texas, United States
Durham, North Carolina, United States
Boston, Massachusetts, United States
Atlanta, Georgia, United States
Minneapolis, Minnesota, United States
Murray, Utah, United States
Burlington, Vermont, United States
Montreal, Quebec, Canada
Patients applied
Trial Officials
Kerry L. Lee, PhD
Principal Investigator
Duke Clinical Research Institute
Eugene Braunwald, MD
Study Chair
Harvard University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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