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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?
Many people are considering using chelation therapy because of the belief that it may treat heart disease. However this has not been scientifically proven. Past studies did not show benefit, but may have been too small to be conclusive. That is why the National Institutes of Health is conducting this large study to find out whether chelation therapy is safe and effective in treating heart disease.

What will you be asked to do?
Before you join the study, you should discuss your participation with your doctor. Your participation in the study will last up to 5 years. During that time, it will be important that you continue your standard heart disease treatments.

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:
Either chelation therapy or placebo solution (an inactive treatment)
Either high-dose vitamins or placebo pills
All participants will receive low-dose vitamins.

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.

Why participate?
Help the medical community find new and effective treatments for heart disease.
Join a nationwide effort to learn whether chelation therapy works.
Your health will be closely monitored while you are enrolled in the study.

Are there any risks or side effects?
Chelation with EDTA has been used to treat heavy metal poisoning such as lead. For this use, there is a low occurrence of side effects. The safety of EDTA for treating heart disease has not been established.

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?
There are no costs for taking part in the study. You should continue to see your regular doctor and maintain your health insurance to cover all medical care not included in the study.

Where is the study taking place?
The study is taking place at more than 100 medical centers, clinics, and physicians' offices across the country. Please call 1-888-644-6226 to find out if you are eligible to take part and to find a location near you.


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