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Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124137
Recruitment Status : Completed
First Posted : July 27, 2005
Last Update Posted : March 15, 2007
Information provided by:
Nuwellis, Inc.

Brief Summary:
The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration (UF) can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patient's breathing.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Aquadex system Drug: IV diuretic Not Applicable

Detailed Description:

Congestive heart failure is an important public health issue. It remains the leading cause of hospitalization in Medicare beneficiaries. Ninety percent of all hospitalizations for CHF are due to fluid overload. Most of the expense related to the management of heart failure is due to hospital-based care; interventions that reduce the amount of time patients spend in the hospital may greatly decrease the cost associated with caring for these patients.

Hospital stay for patients admitted for acute decompensated congestive heart failure (adCHF) is largely dictated by how quickly the signs and symptoms of congestion can be relieved and whether ACE inhibitors can be started safely. Diuretics are usually effective in relieving congestion, but achieving adequate diuresis often requires a process of trial and error. Some patients are simply refractory to oral or intravenous diuretics. Diuretics stimulate adverse neurohormonal systems and can cause progressive azotemia. Bayliss (1977) showed that there is a significant increase in renin and aldosterone levels as a response to diuretic treatment rather than as a result of the heart failure itself. Gottlieb (2002) showed that loop diuretics diminish glomerular filtration rate in patients with heart failure. In addition, as more diuretics are given, serum electrolyte imbalances often occur, requiring additional monitoring of patients.

UF has been used as a therapeutic method to remove excessive fluid in patients for over 30 years. UF removes excess water without causing a significant clinical change in the electrolyte composition of the blood or causes adverse affects on the kidneys and neurohormonal system. Studies have shown that UF increases urine output, increases responsiveness to standard oral therapies and decreases readmission rate. While the usefulness of UF in this patient population has great potential, this form of therapy is not usually performed due to the need for invasive venous access and increased expense i.e. high flow dialysis machines. CHF Solutions has developed the Aquadex System that has FDA market clearance for UF. The advantage of the Aquadex System is its simplicity and the fact that it can be administered by means of peripheral catheters or with a central venous access. Early prospective series and subsequent clinical experience involving adCHF patients have shown that 4 to 8 liters can easily be withdrawn in a short amount of time using the peripheral access approach with the Aquadex System. Volume removal was not associated with disruption of electrolyte balance, worsening of renal distress or impact on blood pressure or heart rate of clinical significance. The Aquadex System is a predictable, safe, and effective way to ensure adequate volume removal that may result in shorter hospital stays, better symptom relief and more efficient dosing of medications for the treatment of adCHF.

The purpose of this study is to determine whether the Aquadex System can improve the acute management of patients with adCHF and maintain this improvement over a period of time compared to IV diuretics. Ultrafiltration in this patient population may decrease length of hospital stay and reduce hospital readmissions for heart failure leading to a significant reduction in costs for the treatment of these patients.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrafiltration Versus IV Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: A Prospective Randomized Clinical Trial
Study Start Date : April 2004
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. Total weight loss during first 48 hours of randomization
  2. Change in dyspnea score during first 48 hours of randomization

Secondary Outcome Measures :
  1. Change in global assessment
  2. Change in quality of life (living with heart failure)
  3. Changes in brain natriuretic peptide (BNP)
  4. Changes in 6 minute walk test
  5. Total fluid loss during first 48 hours of randomization
  6. Changes in blood urea nitrogen (BUN) and creatinine
  7. Changes in renin and aldosterone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients hospitalized with primary diagnosis of acute decompensated congestive heart failure (adCHF)
  • Evidence of fluid overload as indicated by:

    1. pitting edema (2+) of lower extremities;
    2. jugular venous distension;
    3. pulmonary edema or pleural effusion;
    4. ascites;
    5. paroxysmal nocturnal dyspnea or 2-pillow orthopnea

Exclusion Criteria:

  • Acute coronary syndrome
  • Creatinine greater than 3.0
  • Systolic blood pressure less than or equal to 90 mmHg
  • Hematocrit greater than 45%
  • Prior administration of IV vasoactive drugs in the emergency room (ER)
  • Clinical instability requiring pressors during hospitalization
  • Recent use of iodinated contrast material
  • Severe concomitant disease expected to prolong hospitalization
  • Sepsis
  • On or requires renal dialysis
  • Had a cardiac transplant
  • Heparin allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00124137

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United States, Illinois
Midwest Heart Institute
Lombard, Illinois, United States, 60148
Sponsors and Collaborators
Nuwellis, Inc.
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Principal Investigator: Maria R Costanzo, MD Midwest Heart
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00124137    
Other Study ID Numbers: 2004-1
First Posted: July 27, 2005    Key Record Dates
Last Update Posted: March 15, 2007
Last Verified: December 2005
Keywords provided by Nuwellis, Inc.:
acute decompensated heart failure
fluid overload
pulmonary congestion
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Agents
Physiological Effects of Drugs