Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study)
Condition: Heart Failure
MeSH terms: Cardio-Renal Syndrome; Heart Failure
Intervention: Stepped pharmacologic care; Ultrafiltration
Intervention description: Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Decompensated Heart Failure; Acute Decompensated Heart Failure With Cardiorenal Syndrome; Cardiorenal Syndrome; Persistent Congestion; Ultra Filtration

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 < 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