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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: CHF Solutions; National Heart, Lung, and Blood Institute (NHLBI); Nuwellis, Inc.
• Treatments: Diuretics; Vasodilator Agents

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 < 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