Carress HF

Title: CARRESS HF – CARdiorenal REScue Study in Acute Decompensated Heart Failure                                                  

Study Sponsor: Heart Failure Network

Principal Investigator: Casey Lawler, MD

Study Synopsis: Heart failure treatment involves removing excess fluid buildup. This fluid can be removed by medications that will cause an increase in urination and the removal of excess fluid (diuretics) or by direct drainage from the veins (ultrafiltration). The purpose of this study is to evaluate the safety and effectiveness of ultrafiltration for the treatment of patients with persistent congestion (fluid buildup) and cardiorenal syndrome (kidney function which is not normal).  Patients will be assigned to one of 2 different ways of treating their heart condition. Patients have a 50-50 chance (like flipping a coin) of being assigned to either of two treatments.

Study Treatment 1: Standard medical drug therapy: this will include medication (diuretic therapy) through a vein in your arm or by mouth to remove your extra fluid.

Study Treatment 2: Fluid removal by ultrafiltration through a vein in your arm.

The two study treatments above are both currently used in routine treatment for patients with congestive heart failure. 

A total of 200 (100 in each treatment group) hospitalized patients with heart failure and cardiorenal syndrome will take part in the study. You will be followed for 60 days, daily during your hospitalization and with clinic visits at 30 and 60 days after your treatment.

How do I qualify? We will consider patients with heart failure, hospitalized with fluid build-up and increase in creatinine.

Who do I contact for more information? Susan Jagger, RN BSN or contact research at 612.863.3980

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 7 days from the time of admission after receiving IV diuretics
  • pre-hospitalization – onset of cardiorenal syndrome pre-hospitalization must occur within 6 weeks of the index hospitalization in the setting of escalating doses of outpatient loop diuretics  persistent volume overload
• For patients with a pulmonary artery catheter, persistent volume overload will include:
  • pulmonary capillary wedge pressure greater than 22mmHg and one of the following clinical signs: at least 2+ peripheral edema and/or pulmonary edema or pleural effusions on chest x-ray
• For patients without a pulmonary artery catheter, persistent volume overload will include at least two of the following:
  • at least 2+ peripheral edema
  • jugular venous pressure greater than 10 cm on physical examination (or central venous pressure greater than 10 mmHg when measured)
  • pulmonary edema or pleural effusions on chest x-ray

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