Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)
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Purpose
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 point of hospitalization, that person is said to have acute decompensated heart failure (ADHF). Abnormal kidney function in association with cardiac distress, known as cardiorenal syndrome, is a common complication of heart failure and causes further medical problems and need for hospitalization. While there are various effective treatments for heart failure, more research is needed to determine the best treatment for targeting both ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: Stepped pharmacologic care Device: Ultrafiltration |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CARdiorenal REScue Study in Acute Decompensated Heart Failure: CARRESS |
- Change in serum creatinine and weight together as a "bivariate" endpoint [ Time Frame: Measured at Days 1, 2, 3, 4, and 7 ] [ Designated as safety issue: No ]
- Significant weight loss and renal improvement [ Time Frame: Measured at Days 4 and 7 ] [ Designated as safety issue: No ]
- Treatment failure [ Time Frame: Measured at Days 1, 2, 3, 4, 5, 6, and 7 ] [ Designated as safety issue: Yes ]
- Changes in renal function (peak creatinine during hospitalization) [ Time Frame: Measured at Days 7, 30, and 60 ] [ Designated as safety issue: No ]
- Changes in electrolytes [ Time Frame: Measured at Days 4 and 7 ] [ Designated as safety issue: No ]
- Changes in weight [ Time Frame: Measured at Days 7, 30, and 60 ] [ Designated as safety issue: No ]
- Clinical decongestion [ Time Frame: Measured at Days 4, 7, 30, and 60 ] [ Designated as safety issue: No ]
- Total net fluid loss [ Time Frame: Measured at Days 4 and 7 ] [ Designated as safety issue: No ]
- Changes in biomarkers [ Time Frame: Measured at Days 4, 7, and 60 ] [ Designated as safety issue: No ]
- Changes in global assessment and visual analogue scores [ Time Frame: Measured at Days 4 and 7 ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: Measured from enrollment to discharge ] [ Designated as safety issue: No ]
- Changes in daily oral diuretic doses [ Time Frame: Measured before hospitalization, at discharge, and at Days 30 and 60 ] [ Designated as safety issue: No ]
| Enrollment: | 188 |
| Study Start Date: | March 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Participants will receive stepped pharmacologic care
|
Drug: Stepped pharmacologic care
Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.
|
|
Experimental: 2
Participants will receive ultrafiltration
|
Device: Ultrafiltration
All loop diuretics will be discontinued. Treatment will involve slow continuous ultrafiltration until an optimal volume status has been achieved. Ultrafiltration therapy will be initiated after the placement of appropriate intravenous access and will continue until the participant's signs and symptoms of congestion have been optimized. Fluid status will be managed exclusively by ultrafiltration using the Aquadex system 100 (CHF Solutions, Inc.) according to the manufacturer's specifications. The use of vasodilators or inotropic agents will be prohibited unless deemed necessary for rescue therapy.
|
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 fluid buildup in the legs, feet, and/or lungs; shortness of breath; coughing; elevated heart rate; change in appetite; and fatigue. If left untreated, the condition of the heart may deteriorate so far that the person undergoes ADHF. The number of hospitalizations attributed to ADHF has risen significantly, with many people readmitted soon after discharge because of recurring symptoms or further medical complications, such as cardiorenal syndrome. Current heart failure treatments focus on removing excess fluid buildup, often by increasing urination with diuretic medications or by draining directly from the veins. Direct drainage from the veins, also known as ultrafiltration, may be the more effective method for treating people with ADHF and cardiorenal syndrome. This study will compare the safety and effectiveness of ultrafiltration versus standard medical drug therapy in improving renal function and relieving fluid buildup in people hospitalized with ADHF and cardiorenal syndrome.
Participation in this study will last 60 days. All potential participants will undergo initial screening, which will include a medical history, physical exam, blood draws, measurements of fluid intake and urine output, and questionnaires. These same evaluations and procedures will be repeated at various points during the hospital stay. Eligible participants will be randomly assigned to receive standard medical drug therapy or fluid removal by ultrafiltration. Standard medical drug therapy will involve the intravenous delivery of diuretics and possibly other doctor-recommended medications. Ultrafiltration will involve intravenously removing blood, passing it through an ultrafiltration device, and then returning the blood to the participant. During ultrafiltration, participants will be treated with a blood thinner through the IV, as well.
Follow-up assessments will occur at Days 30 and 60 after treatment. Follow-up assessments will include measurements of fluid intake, urine output, and vital signs; blood draws; physical exams; and questions about medications and status of recovery.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Arizona | |
| Phoenix, Arizona, United States, 85054 | |
| United States, Georgia | |
| Morehouse School of Medicine | |
| Atlanta, Georgia, United States, 30310 | |
| United States, Minnesota | |
| Minnesota Heart Failure Network | |
| Minneapolis, Minnesota, United States, 55415 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah Health Sciences Center | |
| Murray, Utah, United States, 84107 | |
| United States, Vermont | |
| University of Vermont - Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401 | |
| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T - 1C8 | |
| Principal Investigator: | Kerry L. Lee, PhD | Duke Clinical Research Institute |
More Information
Publications:
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00608491 History of Changes |
| Other Study ID Numbers: | Pro00018064, U01HL084904-04, U01 HL084904, 522 |
| Study First Received: | January 25, 2008 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Duke University:
|
Acute Decompensated Heart Failure Acute Decompensated Heart Failure With Cardiorenal Syndrome Cardiorenal Syndrome Persistent Congestion Ultra Filtration |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013