Status:
COMPLETED
Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Nuwellis, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Heart failure is a serious condition in which the heart's ability to pump blood through the body is impaired, often making a person feel weak or fatigued. When a person's condition worsens to the poin...
Detailed Description
Heart failure is a common condition that affects approximately 5 million people in the United States, with 550,000 new cases diagnosed each year. Common symptoms of heart failure include swelling and ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age 18 or older
- admitted to the hospital with a primary diagnosis of decompensated heart failure
- onset of cardiorenal syndrome after hospitalization or pre-hospitalization
- after hospitalization - onset of cardiorenal syndrome after hospitalization must occur within 10 days from the time of admission after receiving IV diuretics
- pre-hospitalization - onset of cardiorenal syndrome pre-hospitalization must occur within 12 weeks of the index hospitalization in the setting of escalating doses of outpatient diuretics
- persistent volume overload
- Exclusion criteria:
- intravascular volume depletion based on investigator"s clinical assessment
- acute coronary syndrome within 4 weeks
- indication for hemodialysis
- creatinine \> 3.5 mg per deciliter at admission to the hospital
- systolic blood pressure \< 90 mmHg at the time of enrollment
- alternative explanation for worsening renal function such as obstructive nephropathy,contrast induced nephropathy, acute tubular necrosis
- Hematocrit \> 45%
- poor venous access
- clinical instability likely to require the addition of intravenous vasoactive drugs including vasodilators and/or inotropic agents
- allergy or contraindications to the use of heparin
- the use of iodinated radio contrast material in the last 72 hours or anticipated use of IV contrast during the current hospitalization
- known bilateral renal artery stenosis
- active myocarditis
- hypertrophic obstructive cardiomyopathy
- severe valvular stenosis
- complex congenital heart disease
- sepsis or ongoing systemic infection
- enrollment in another clinical trial involving medical or device based interventions
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00608491
Start Date
March 1 2008
End Date
June 1 2012
Last Update
June 24 2013
Active Locations (9)
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1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
3
Minnesota Heart Failure Network
Minneapolis, Minnesota, United States, 55415
4
Mayo Clinic
Rochester, Minnesota, United States, 55905