Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
CHF Solutions
ClinicalTrials.gov Identifier:
NCT00124137
First received: July 25, 2005
Last updated: March 14, 2007
Last verified: December 2005
  Purpose

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 Intervention
Congestive Heart Failure
Device: Aquadex system
Drug: IV diuretic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrafiltration Versus IV Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: A Prospective Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by CHF Solutions:

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

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

Estimated Enrollment: 200
Study Start Date: April 2004
Estimated Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124137

Locations
United States, Illinois
Midwest Heart Institute
Lombard, Illinois, United States, 60148
Sponsors and Collaborators
CHF Solutions
Investigators
Principal Investigator: Maria R Costanzo, MD Midwest Heart
  More Information

No publications provided by CHF Solutions

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00124137     History of Changes
Other Study ID Numbers: 2004-1
Study First Received: July 25, 2005
Last Updated: March 14, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by CHF Solutions:
Ultrafiltration
acute decompensated heart failure
fluid overload
pulmonary congestion

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Diuretics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014