Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)
Ultrafiltration Versus IV Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: A Prospective Randomized Clinical Trial
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 25, 2005
CompletedFirst Posted
Study publicly available on registry
July 27, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedMarch 15, 2007
December 1, 2005
July 25, 2005
March 14, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total weight loss during first 48 hours of randomization
Change in dyspnea score during first 48 hours of randomization
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Patients hospitalized with primary diagnosis of acute decompensated congestive heart failure (adCHF)
- Evidence of fluid overload as indicated by:
- pitting edema (2+) of lower extremities;
- jugular venous distension;
- pulmonary edema or pleural effusion;
- ascites;
- paroxysmal nocturnal dyspnea or 2-pillow orthopnea
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nuwellis, Inc.lead
Study Sites (1)
Midwest Heart Institute
Lombard, Illinois, 60148, United States
Related Publications (1)
Costanzo MR, Guglin ME, Saltzberg MT, Jessup ML, Bart BA, Teerlink JR, Jaski BE, Fang JC, Feller ED, Haas GJ, Anderson AS, Schollmeyer MP, Sobotka PA; UNLOAD Trial Investigators. Ultrafiltration versus intravenous diuretics for patients hospitalized for acute decompensated heart failure. J Am Coll Cardiol. 2007 Feb 13;49(6):675-83. doi: 10.1016/j.jacc.2006.07.073. Epub 2007 Jan 26.
PMID: 17291932DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria R Costanzo, MD
Midwest Heart
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 25, 2005
First Posted
July 27, 2005
Study Start
April 1, 2004
Study Completion
October 1, 2005
Last Updated
March 15, 2007
Record last verified: 2005-12