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Search / Trial NCT00577135

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

Loop Diuretics Furosemide Fluid Overload Cardio Renal Failure

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.

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

0 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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