Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)

Phase 3

Completed

Conditions: Heart Failure

Interventions: Drug: Stepped pharmacologic care
Device: Ultrafiltration

Registration Number: NCT00608491

Lead Sponsor: Duke University

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 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 188

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepped pharmacologic care	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.
Ultrafiltration	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.

Primary Outcome Measures

Name	Time	Method
Change in Serum Creatinine	Change from Baseline to Day 4
Change in Weight	Change from Baseline to Day 4

Secondary Outcome Measures

Name	Time	Method
Change in Glomerular Filtration Rate	Change from Baseline to Day 7
Change in Serum Creatinine	Change from Baseline to Day 7
Changes in Weight	Change from Baseline to Day 5
Change in Weight	Change from Baseline to Day 6
Cumulative Net Fluid Loss	Randomization through Day 7
Change in Blood Sodium Level	Baseline to Day 7/Discharge
Change in Blood Potassium Level	Baseline to Day 7/Discharge
Change in Blood Urea Nitrogen/Urea	Baseline to Day 7/Discharge
Change in Blood Bicarbonate Level	Baseline to Day 7/Discharge
Change in Blood Hemoglobin Level	Baseline to Day 7/Discharge
Change in Blood Cystatin C	Baseline to Day 60
Change in Uric Acid	Baseline to Day 4
Change in Blood N- Terminal Pro- BNP	Baseline to Day 4
Change in Plasma Renin Activity	Baseline to Day 60
Change in Blood High Sensitivity Troponin I	Baseline to Day 60
Change in Blood Aldosterone	Baseline to Day 60
Creatinine Change	Baseline to Day 30
Glomerular Filtration Rate Change	Baseline to Day 30
Dyspnea Visual Analog Scale	Change from Baseline to Day 4	Scale range: -100 , +100 -100=worse, +100=better
Change in Global Visual Analog Scale	Baseline to Day 7/Discharge	Scale range: -100 , +100 -100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled "best you have ever felt" and the bottom labeled "worst you have ever felt".
Change in Dyspnea Visual Analog Scale	Baseline to Day 7/Discharge	Scale range: -100 , +100 -100=worse, +100=better
Change in Furosemide-Equivalent Dose	Baseline to Day 60	Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)
Change in Blood Procollagen III N-terminal Propepide	Baseline to Day 60
Change in Blood Endothelin-1	Baseline to Day 60
Change in Blood High Sensitivity C-Reactive Protein	Baseline to Day 60
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I	Baseline to Day 60
Change in Blood Uric Acid	Baseline to Day 60
Change in Blood N Terminal Pro-Natriuretic Peptide	Baseline to Day 7/Discharge
Weight Change	Baseline to Day 60
Best Available Serum Creatinine Change	Baseline to Day 60	Core laboratory when available. If not available, local laboratory results were used.
Best Available Glomerular Filtration Rate Change	Baseline to Day 60	Core laboratory when available. If not available, local laboratory results were used.
Change in Blood N Terminal Pro - B Natriuretic Peptides	Baseline to Day 60

Trial Locations

Locations (9): Mayo Clinic Arizona
🇺🇸
Phoenix, Arizona, United States
University of Utah Health Sciences Center
🇺🇸
Murray, Utah, United States
University of Vermont - Fletcher Allen Health Care
🇺🇸
Burlington, Vermont, United States
Minnesota Heart Failure Network
🇺🇸
Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Morehouse School of Medicine
🇺🇸
Atlanta, Georgia, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States