Baxter Healthcare Corporation has announced the launch of a unique phase II clinical trial to determine if adding peritoneal ultra filtration treatments using its proprietary icodextrin solution to the current standard Congestive Heart Failure (CHF) therapy regimen will improve clinical outcomes and reduce the amount of time patients spend in the hospital.

CHF is a serious heart condition in which blood flow slows and starts to back up, causing congestion in the tissues and abnormal fluid retention that usually results in swelling (edema). One of the dramatic symptoms is tiredness and shortness of breath, which is caused by the accumulation of fluid in the lungs. In the trial, researchers will use peritoneal ultra filtration to remove excess salt and water in CHF patients and reduce their edema.

"Peritoneal ultra filtration could be the next frontier in helping to manage treatment-resistant CHF - one of the largest unmet needs in medicine today.
This may prove to be an innovative new way to improve fluid management in patients in advanced stages of the disease. We believe it could not only dramatically improve their quality of life, but also do it in a way that is less invasive than current alternative therapies said Sarah S Prichard, MD, vice president of global medical/clinical affairs and research for Baxter's Renal business."

The trial, which is called "Peritoneal ultra filtration in treatment-resistant congestive heart failure," is a two-year prospective, randomised, open-labeled controlled evaluation that will enrol 104 patients with treatment-resistant severe heart failure at 16 sites in the US, Canada, Belgium and Australia.

At each site, patients will be randomly selected to receive either the current standard CHF therapy or the standard therapy plus peritoneal ultra filtration using Baxter's proprietary icodextrin solution. In this process, the solution is infused through a catheter into the abdominal cavity, which is lined by the peritoneal membrane. This membrane serves as a natural filter, across which the solution draws out toxins and fluid. The used solution is then drained from the body. The treatment period will be six to 24 months with the primary outcome measure being impact on hospitalisation rate. Also being evaluated is the effect on quality of life and medication use.

Stuart M Sprague, DO, Clinical Investigator and Professor of Medicine in Nephrology, said, "Evanston Northwestern Healthcare is excited to participate in this trial, especially since the pilot study we were involved with showed the potential for decreasing hospitalisations and improving quality of life. Studies have shown that ultra filtration can more effectively remove fluid than medication. This trial is a major milestone in treating fluid overload in refractory CHF, and if successful, would be a major advancement in this area."

Heart failure affects approximately five mn patients in the US, and more than 550,000 new patients are diagnosed each year. Current treatments for those with CHF depend on the severity of the condition, and range from getting more rest, appropriate exercise and improving diet to using a variety of drugs, including diuretics to help the body eliminate excess salt and water - an important aspect of treatment in that they improve the congestive symptomatology, which typifies the more advanced stages of CHF.

The impact CHF has on the healthcare system is staggering. In the US, the annual cost of inpatient care for CHF patients is estimated at $23 bn. It is the primary reason for 12 to 15 mn office visits and 6.5 mn hospital days each year. Heart failure is Medicare's most common diagnosis-related group, and Medicare spends more dollars on its diagnosis and treatment than any other group.

"Approximately one mn US hospital admissions per year are attributable to a primary diagnosis of acutely decompensated heart failure - and 90 per cent are due to fluid overload," notes Prichard. "Ultimately our goal in this trial is to have an impact both clinically and economically. There is a very real opportunity to significantly reduce the costs of CHF care, emergency visits, admissions and length of stay."