Drug Therapy for the Treatment of Anemic Patients with Congestive Heart Failure

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This research study is being done to see if the investigational use of the drug darbepoetin alfa, which is given to treat anemia (low number of red blood cells), will have an effect on your ability to exercise on a treadmill and on your clinical symptoms.  Previous observations in a small number of patients suggests that improved blood counts may improve these symptoms.

Who is eligible to participate?

Men or women 21 or older who have been diagnosed with anemia and congestive heart failure may be eligible to participate.

This drug was developed to treat anemia (a low number of red blood cells).  Darbepoetin alfa has been approved by the FDA for treatment of anemia in patients with chronic kidney disease and for the treatment of anemia in patients with cancer who have anemia from chemotherapy treatment. More than 7000 patients with chronic kidney disease or cancer have received darbepoetin alfa in research studies.

Additional Requirements / Information

What is involved in this research study?

If you agree to take part in this research study, your
participation may last up to approximately 58 weeks. There will be an initial 2 to 4 week screening period, a 52-week treatment period, and a 1-week post-treatment period. You will also receive a phone call from the study nurse 4 weeks after your post-treatment visit. You will be asked to visit your study doctor?s office every week initially and then at least every two weeks during the study.

If you qualify for the study, you will be randomly assigned(like flipping a coin) into one of two treatment groups.  You have a 50% chance of being assigned to receive darbepoetin alfa (study drug) and a 50% chance of being assigned to receive placebo (inactive substance). Neither you nor your doctor will know which treatment group you have been assigned to. Both treatment groups will receive either the study drug or placebo by subcutaneous (under the skin) injection in an area like your upper arm, thigh, or abdomen. This is similar to how diabetics receive insulin.

IRB Number:

1049-02