In the United States, heart disease stands as the primary cause of death among both women and men. One common form, coronary artery disease, occurs when the heart's blood vessels struggle to supply enough oxygen-rich blood. This type affects millions and causes over 370,000 fatalities annually. Management typically includes healthier lifestyle choices, such as eating better and quitting smoking, alongside medications and sometimes medical procedures.

Disodium EDTA chelation therapy has been explored as a complementary approach for coronary artery disease. This summary reviews what chelation therapy involves and presents findings from two major studies funded by the National Institutes of Health (NIH).

What is chelation therapy?

This therapy involves delivering a chemical through the veins that binds with metals or minerals in order to help eliminate them from the body. For those with heart disease, this treatment is administered through IV infusions, often requiring 20 to 40 sessions, each lasting several hours. Patients also usually take high doses of supplemental vitamins and minerals during the therapy period.

Is EDTA chelation approved by the FDA for coronary heart disease?

No. The use of EDTA chelation to treat coronary artery disease has not received approval from the U.S. Food and Drug Administration.

What research has been done on chelation therapy for coronary artery disease?

Two NIH-sponsored studies have assessed chelation therapy for coronary artery disease: the original TACT study and its follow-up, TACT2.

First Trial: TACT

• Conducted from 2003 to 2011 with findings released in 2013, TACT involved 1,708 individuals aged 50 and older who had experienced a heart attack. They were randomly assigned to receive either EDTA infusions or a placebo, alongside high-dose supplements or placebo pills. Participants were unaware of the treatment group they were in.
• The overall results showed a slight reduction in heart-related events, although this benefit was observed primarily among participants with diabetes.
• Among diabetic participants, cardiovascular events dropped by 41%, with specific reductions of 40% for death, stroke, and nonfatal heart attacks; 52% fewer recurrent heart attacks; and 43% less risk of death over roughly five years.
• Vitamins and minerals showed no significant benefits, though they appeared to be generally safe despite a high dropout rate.
• Because this was the first large trial to show a benefit, additional research was necessary before recommending chelation for patients with diabetes post–heart attack. The TACT2 study was designed to confirm the original findings.

Follow-Up Trial: TACT2

• Running from 2016 to 2023, TACT2 included 1,000 participants—959 of whom underwent treatment. These individuals were over age 50, had diabetes, and had previously suffered a heart attack. Like in TACT, participants received 40 infusions of either EDTA or a placebo and were given supplement or placebo pills.
• This study introduced the measurement of blood lead and urine cadmium levels to assess whether chelation effectively removed heavy metals, which may be linked to heart disease.
• While EDTA successfully lowered lead levels and temporarily raised cadmium excretion, cardiovascular event rates remained nearly identical between the therapy group (35.6%) and the placebo group (35.7%).
• Conclusions about the value of vitamin and mineral supplementation in TACT2 are still pending.
• The lack of similar positive results in TACT2 suggests that chelation may not be effective in reducing heart risks for diabetics with previous heart attacks.

Why were the TACT and TACT2 outcomes different?

The exact reasons remain unclear. Ongoing analysis of TACT2 data may provide answers. Differences in participant characteristics could explain the discrepancy—TACT2 individuals generally had more advanced heart disease and may have had lower exposure to heavy metals like lead. However, it is not yet certain whether these differences are the key factors behind the varying outcomes.

What are the risks of chelation therapy?

Although chelation can be helpful in specific cases, it may cause serious side effects, including dangerously low calcium levels and possible kidney damage.

In TACT, 11.9% of patients receiving chelation and 14.6% of those in the placebo group experienced serious health events. In TACT2, adverse events were seen in 16.8% of the chelation group and 16.6% of the placebo group.

Are over-the-counter chelation products effective and safe?

No. The FDA has advised against the use of chelation supplements and similar consumer products. These are not approved for medical use and may cause harm, particularly if individuals rely on them instead of seeing a medical professional for a serious condition.

Concerned about heavy metal exposure?

If you suspect high lead exposure, it’s important to speak with a healthcare provider. Testing and proper treatment can help address health issues related to lead or similar toxic substances.

Additional Considerations

• Consult your healthcare provider before beginning chelation therapy for heart disease. It's important to review available scientific evidence first.
• Take an active role in your care. Communicate openly with your doctor about any complementary treatments you're considering to make informed decisions together.

Where to Learn More

NCCIH Clearinghouse

Offers educational materials and access to scientific and medical research databases related to complementary and integrative health approaches. It does not offer personalized medical advice or referrals.

Phone: 1-888-644-6226

TRS: 7-1-1

Understanding Science

The NIH and NCCIH provide tools to better understand medical studies. These resources include interactive guides, quizzes, and explainer videos to help you interpret health information accurately.

PubMed®

PubMed is a service managed by the National Library of Medicine that indexes a wide array of scientific papers in healthcare. It also includes tools and guidance for exploring health-related research.

Selected Research Sources

• Escolar E, et al. Effects of EDTA chelation on heart patients with diabetes. Circulation: Cardiovascular Quality and Outcomes, 2014.
• Lamas GA, et al. TACT2 results on chelation and heart disease. JAMA, 2024.
• Lamas GA, et al. Planning and structure of TACT2. American Heart Journal, 2022.
• Lamas GA, et al. Combined EDTA chelation and vitamins study. American Heart Journal, 2014.
• Lamas GA, et al. Multivitamin use post–heart attack. Annals of Internal Medicine, 2013.
• Lamas GA, et al. TACT results on cardiac events. JAMA, 2013.

Additional Resources

• Centers for Disease Control and Prevention. Heart disease statistics, 2024.
• Lamas GA. Updated views on chelation for diabetic heart patients. Circulation, 2015.
• Lamas GA, et al. TACT study design. American Heart Journal, 2012.
• National Heart, Lung, and Blood Institute. Coronary heart disease treatment guidelines, 2024.
• Sultan S, et al. Chelation in cardiovascular care: A review. Expert Review of Clinical Pharmacology, 2017.
• FDA. Public guidance on unapproved chelation products.

This material is publicly available and not copyrighted. Reuse is encouraged.

This article is for informational purposes only. It is not intended to substitute for medical guidance from a qualified healthcare provider. You should always consult with your provider about personal health decisions. Mention of specific treatments does not imply endorsement.