Phase 3
N=188
Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00608491 ↗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
| Outcome | Result | p-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
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.