What is chelation therapy?
Chelation (pronounced key-LAY-shun) therapy is an investigational therapy using a man-made amino acid, called EDTA. It is added to the blood through a vein. A national research study is now testing whether chelation therapy is safe and effective for treating heart disease.
Why is this study being conducted?
What will you be asked to do?
You will be randomly assigned to receive one of several different treatment combinations. Randomly assigning people to treatment groups helps ensure that the treatments can be compared objectively.
You will receive:
You will visit your study site for your treatments once a week for 30 weeks. Then, you will have 10 more visits, between 2 weeks and 2 months apart. Each treatment will take about 3 hours. The study team will work with you to schedule your visits at a time that works best for you. Remember, participation in this study is your choice. You can leave the study at any time.
Are there any risks or side effects?
The most common side effect is a burning sensation at the site where the EDTA is delivered into the vein. Rare side effects can include fever, headache, nausea, and vomiting. Even more rare are serious side effects that can include a sudden drop in blood pressure, abnormally low calcium levels in the blood, permanent kidney damage, and bone marrow depression (meaning that blood cell counts fall). Reversible injury to the kidneys, although infrequent, has been reported with EDTA chelation therapy. Other serious side effects can occur if EDTA is not administered by a trained health professional.
In addition, because chelation therapy removes important vitamins and minerals from the body, it will be very important for you to take the vitamin supplements supplied by the study. It is also important that you continue to take your standard heart disease treatments.
What are the costs?
Where is the study taking place?