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Phase 3 N=188 Randomized Treatment

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

Heart Failure

Enrolled (actual)
188
Serious AEs
64.9%
Results posted
Jun 2013
Primary outcome: Primary: Change in Serum Creatinine — -0.04; 0.23 mg/dL

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Stepped pharmacologic care (Drug); Ultrafiltration (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Duke University
Primary completion
Mar 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Serum Creatinine
-0.00; 0.11
PRIMARY
Change in Weight
-12.1; -12.6
SECONDARY
Change in Glomerular Filtration Rate
2.06; 1.82
SECONDARY
Change in Serum Creatinine
-0.00; 0.11
SECONDARY
Change in Glomerular Filtration Rate
2.06; 1.82
SECONDARY
Changes in Weight
-15.6; -14.3
SECONDARY
Changes in Weight
-15.6; -14.3
SECONDARY
Change in Weight
-12.1; -12.6
SECONDARY
Changes in Weight
-15.6; -14.3
SECONDARY
Change in Weight
-12.1; -12.6
SECONDARY
Cumulative Net Fluid Loss
11659.6; 10595.1
SECONDARY
Cumulative Net Fluid Loss
11659.6; 10595.1
SECONDARY
Cumulative Net Fluid Loss
11659.6; 10595.1
SECONDARY
Cumulative Net Fluid Loss
11659.6; 10595.1
SECONDARY
Cumulative Net Fluid Loss
11659.6; 10595.1
SECONDARY
Cumulative Net Fluid Loss
11659.6; 10595.1
SECONDARY
Cumulative Net Fluid Loss
11659.6; 10595.1
SECONDARY
Dyspnea Visual Analog Scale
20.5; 16.5
SECONDARY
Change in Global Visual Analog Scale
25.8; 16.9
SECONDARY
Change in Dyspnea Visual Analog Scale
22.8; 19.4
SECONDARY
Change in Global Visual Analog Scale
25.8; 16.9
SECONDARY
Change in Furosemide-Equivalent Dose
-12.4; 8.8
SECONDARY
Change in Blood Sodium Level
-0.49; -2.02
SECONDARY
Change in Blood Potassium Level
-0.14; 0.27
SECONDARY
Change in Blood Urea Nitrogen/Urea
7.23; 13.81
SECONDARY
Change in Blood Bicarbonate Level
3.07; -0.70
SECONDARY
Change in Blood Hemoglobin Level
0.35; -0.02
SECONDARY
Change in Blood Sodium Level
-0.49; -2.02
SECONDARY
Change in Blood Potassium Level
-0.14; 0.27
SECONDARY
Change in Blood Urea Nitrogen/Urea
7.23; 13.81
SECONDARY
Change in Blood Bicarbonate Level
3.07; -0.70
SECONDARY
Change in Blood Hemoglobin Level
0.35; -0.02
SECONDARY
Change in Blood Cystatin C
-0.18; -0.03
SECONDARY
Change in Uric Acid
1.06; -0.23
SECONDARY
Change in Blood N- Terminal Pro- BNP
-978.61; -814.45
SECONDARY
Change in Plasma Renin Activity
-2.18; 0.54
SECONDARY
Change in Blood High Sensitivity Troponin I
-17.48; -73.58
SECONDARY
Change in Blood Aldosterone
-6.91; 40.35
SECONDARY
Change in Blood Procollagen III N-terminal Propepide
0.75; 0.58
SECONDARY
Change in Blood Endothelin-1
-0.82; -1.32
SECONDARY
Change in Blood High Sensitivity C-Reactive Protein
-13.62; 1.99
SECONDARY
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
2.24; 4.57
SECONDARY
Change in Blood Cystatin C
-0.18; -0.03
SECONDARY
Change in Blood Uric Acid
-0.31; -0.54
SECONDARY
Change in Blood N Terminal Pro-Natriuretic Peptide
-1071.88; -740.82
SECONDARY
Change in Plasma Renin Activity
-2.18; 0.54
SECONDARY
Change in Blood High Sensitivity Troponin I
-17.48; -73.58
SECONDARY
Change in Blood Aldosterone
-6.91; 40.35
SECONDARY
Change in Blood Procollagen III N-terminal Propepide
0.75; 0.58
SECONDARY
Change in Blood Endothelin-1
-0.82; -1.32
SECONDARY
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
2.24; 4.57
SECONDARY
Change in Blood High Sensitivity C-Reactive Protein
-13.62; 1.99
SECONDARY
Weight Change
-17.2; -15.4
SECONDARY
Change in Furosemide-Equivalent Dose
-12.4; 8.8
SECONDARY
Creatinine Change
-0.25; -0.12
SECONDARY
Glomerular Filtration Rate Change
7.95; 6.07
SECONDARY
Weight Change
-17.2; -15.4
SECONDARY
Change in Furosemide-Equivalent Dose
-12.4; 8.8
SECONDARY
Best Available Serum Creatinine Change
-0.28; -0.12
SECONDARY
Best Available Glomerular Filtration Rate Change
8.86; 5.63
SECONDARY
Change in Blood Uric Acid
-0.31; -0.54
SECONDARY
Change in Blood Cystatin C
-0.18; -0.03
SECONDARY
Change in Blood N Terminal Pro - B Natriuretic Peptides
-490.56; -937.69
SECONDARY
Change in Plasma Renin Activity
-2.18; 0.54
SECONDARY
Change in Blood High Sensitivity Troponin I
-17.48; -73.58
SECONDARY
Change in Blood Aldosterone
-6.91; 40.35
SECONDARY
Change in Blood Procollagen III N-terminal Propepide
0.75; 0.58
SECONDARY
Change in Blood Endothelin-1
-0.82; -1.32
SECONDARY
Change in Blood High Sensitivity C-Reactive Protein
-13.62; 1.99
SECONDARY
Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
2.24; 4.57

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.

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00608491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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