Baxter begins phase II trials for CHF patients

Baxter Healthcare Corporation has begun phase II of trials for a new form of treatment for patients with congestive heart failure (CHF).

The trial, which is taking place at 16 sites worldwide, will determine if peritoneal ultrafiltration treatments using Baxter’s proprietary icodextrin solution will help to reduce the amount of time CHF patients spend in the hospital.

CHF is a serious heart condition in which blood flow slows, causing congestion in the tissues and abnormal fluid retention – leading to swelling (edema) as well as tiredness and shortness of breath.

Using the ultrafiltration technique, the icodextrin solution will be infused through a catheter into the abdominal cavity. There the solution draws out toxins and fluid, before being drained from the body.

The two-year prospective, randomised, open-labelled controlled trial will enroll 104 patients with treatment-resistant severe heart failure at sites in the US, Canada, Belgium and Australia.

Stuart M Sprague, clinical investigator and professor of medicine in nephrology, said: “Evanston Northwestern Healthcare is excited to participate in this trial.”

He added: “Studies have shown that ultrafiltration 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 million patients in the US and more than 550,000 new patients are diagnosed each year.