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Chelation Therapy for Heart Disease: The TACT Trial and Beyond

EDTA chelation therapy has been studied in major NIH-funded trials for cardiovascular disease. Learn about the TACT study results, how chelation may benefit heart health and what this means for Nova Scotians.

Dr. Colin MacLeod ND
Dr. Colin MacLeod ND
Updated December 3, 2024
Chelation Therapy for Heart Disease: The TACT Trial and Beyond

Heart disease remains the second leading cause of death in Canada, claiming thousands of lives each year.1 Nova Scotia has among the highest rates of ischemic heart disease in the country, with prevalence reaching 9.7%, the highest of any Canadian province.2 While conventional treatments like medications, stents and bypass surgery remain important, many patients are seeking additional options to improve their cardiovascular health. EDTA chelation therapy has emerged as a promising complementary approach, backed by the largest NIH-funded trial ever conducted on this treatment.

The TACT Trial: A Landmark Study

The Trial to Assess Chelation Therapy (TACT) was a groundbreaking $30 million study funded by the National Institutes of Health (NIH) and the National Center for Complementary and Integrative Health (NCCIH).3 This rigorous, double-blind, placebo-controlled trial enrolled 1,708 patients who had previously suffered a heart attack.

Study Design

Participants were randomly assigned to receive either:

  • Active treatment: 40 infusions of a chelation solution containing 3 grams of disodium EDTA, 7 grams of ascorbic acid, 2 grams of magnesium chloride and other components
  • Placebo: An identical-appearing infusion without the active chelating agent

The study followed patients for up to 5 years, tracking major cardiovascular events including death, heart attack, stroke, coronary revascularization and hospitalization for angina.4

Key Findings

The TACT results, published in the Journal of the American Medical Association (JAMA), showed significant benefits. The chelation group experienced an 18% reduction in cardiovascular events overall.4 The number needed to treat (NNT) was 18 patients over 5 years to prevent one cardiovascular event, and the treatment was well-tolerated with an excellent safety profile.5

Remarkable Benefits for Diabetic Patients

The most striking findings emerged from a pre-specified subgroup analysis of patients with diabetes. This group showed a 41% reduction in cardiovascular events and a 43% reduction in all-cause mortality.6 Event rates dropped from 38% to 25% over 5 years in the chelation group.6 These results were so compelling that the American Heart Association and American College of Cardiology upgraded EDTA chelation from a Class III (not recommended) to a Class IIb indication in their 2014 guidelines for chronic ischemic heart disease.7

How Does Chelation Help Heart Disease?

EDTA (ethylene diamine tetraacetic acid) chelation therapy works through several proposed mechanisms to benefit cardiovascular health:

1. Removal of Toxic Heavy Metals

The American Heart Association released a scientific statement in 2023 confirming that toxic metals such as lead, cadmium and arsenic are significant cardiovascular risk factors.8 Even at levels previously considered “safe,” these metals increase the risk of heart attack,9 stroke,10 peripheral artery disease11 and cardiovascular death.12

Research published in the Journal of the American Heart Association found that comparing high versus low blood lead levels, the pooled relative risks were 1.43 for cardiovascular disease, 1.85 for coronary heart disease and 1.63 for stroke.13 EDTA has a high affinity for these toxic metals and effectively removes them from the body, reducing their harmful effects on blood vessels.14

2. Reduction of Oxidative Stress

Heavy metals catalyze the formation of free radicals, highly reactive molecules that damage blood vessel walls and promote atherosclerosis.15 By removing iron, copper and other metals that drive oxidative stress, chelation therapy may help reduce inflammation and protect the endothelium (the lining of blood vessels).16

3. Improved Endothelial Function

The endothelium produces nitric oxide, a molecule essential for healthy blood vessel dilation and cardiovascular function. Toxic metal exposure impairs nitric oxide production and endothelial function.17 Chelation therapy may restore healthier endothelial function by removing these interfering metals.

4. Calcium Binding and Arterial Compliance

EDTA also binds calcium, potentially softening calcified plaques and improving arterial flexibility.18 While the extent of this effect is debated, improved arterial compliance may enhance blood flow and reduce cardiovascular strain.

Understanding the TACT2 Trial

Following the positive TACT results, a follow-up study called TACT2 was conducted specifically in diabetic patients who had suffered a heart attack. This was the group that showed the most benefit in the original trial.19

TACT2, which enrolled 959 patients between 2015 and 2020, did not replicate the dramatic benefits seen in TACT. The primary outcome occurred in 35% of both the chelation and placebo groups.19

Why the Different Results?

Several factors may explain this difference:

Lower baseline lead levels: Blood lead levels in the US and Canada have dropped 35% since the TACT era due to reduced environmental exposure.19 With less toxic metal burden, there may be less benefit from chelation.

Improved background therapy: TACT2 patients had access to newer cardiovascular medications including SGLT2 inhibitors and GLP-1 receptor agonists with proven cardiovascular benefits that weren’t available during TACT.20

Different patient population: While both trials studied diabetic post-heart attack patients, the improved survival rates with modern therapy may have changed the population characteristics.

The TACT2 investigators noted that in areas with higher environmental lead exposure, which includes many regions outside North America, chelation therapy may still provide significant cardiovascular benefits.19

Heavy Metals and Heart Disease: The Evidence

The connection between toxic metal exposure and cardiovascular disease is now well-established:

Lead

Blood lead concentrations, even at levels considered safe, are associated with coronary artery calcification.21 Lead exposure increases oxidative stress and impairs endothelial function,22 and epidemiological studies consistently link lead to increased cardiovascular mortality.23

Cadmium

A dose-response meta-analysis found a relative risk of 2.58 for cardiovascular disease at blood cadmium levels of 1 μg/L.24 Cadmium is independently associated with hypertension, stroke and peripheral artery disease.25

Combined Effects

A study published in Circulation found that higher blood levels of lead and cadmium were associated with a 15-85% higher risk for stroke and heart disease.26 These metals improve the ability to predict cardiovascular mortality beyond traditional risk factors alone.

Heart Disease in Nova Scotia

Nova Scotians face particular cardiovascular health challenges. The province has the highest ischemic heart disease prevalence in Canada at 9.7%,2 along with elevated rates of hypertension and diabetes, both major cardiovascular risk factors.27 Additionally, older homes and infrastructure in the region may contribute to lead exposure. Given these statistics, exploring all evidence-based options for cardiovascular health is particularly important for our region.

Sources of Heavy Metal Exposure

Common sources of toxic metal exposure vary by metal type. Lead exposure typically comes from older home plumbing (especially pre-1950s homes), lead paint in homes built before 1978, contaminated drinking water, certain occupational settings and some imported goods and cosmetics.

Cadmium exposure occurs primarily through cigarette smoke, but also through contaminated foods such as leafy vegetables and grains, occupational exposure in manufacturing and some jewelry and pottery glazes.

Arsenic exposure sources include contaminated well water, some rice products, treated lumber (older pressure-treated wood) and certain occupational settings.

What to Expect During Chelation Treatment

A typical chelation therapy program for cardiovascular health involves several stages.

Initial Assessment

Before starting chelation, a comprehensive evaluation is performed. This includes a complete medical history, cardiovascular risk assessment, baseline laboratory testing, heavy metal testing (blood or provoked urine challenge) and kidney and liver function tests.

Treatment Protocol

For optimal cardiovascular benefit, most patients receive 15-25 infusions, typically scheduled once weekly. Each infusion takes 1.5-3 hours and includes EDTA, vitamin C, magnesium and other supportive nutrients.

Expected Improvements

Patients may experience reduced chest pain (angina), improved circulation to extremities, increased energy and exercise tolerance and better overall cardiovascular function.

Important Precautions

Hydration: Adequate water intake before, during and after treatment is essential. Most side effects are related to dehydration.

Blood sugar: Chelation can temporarily lower blood sugar. Eating a protein-containing meal before treatment helps prevent this.

Mineral supplementation: Because EDTA removes some healthy minerals along with toxic metals, a quality multi-mineral supplement is required during treatment.

Contraindications: Chelation should be avoided in pregnancy, acute liver disease, advanced kidney disease and severe congestive heart failure.

Safety of Chelation Therapy

When administered by properly trained practitioners following established protocols, EDTA chelation therapy has an excellent safety record. The TACT trial, which provided over 55,000 infusions, confirmed the safety of this approach with no serious adverse events related to chelation.4

Common temporary effects may include mild fatigue during or after treatment, a temporary drop in blood pressure or a burning sensation at the IV site (usually related to infusion rate). These effects are generally manageable and resolve quickly.

Who May Benefit from Chelation?

Based on current evidence, chelation therapy for cardiovascular health may be most appropriate for individuals with documented heavy metal exposure or elevated levels, those with coronary artery disease seeking complementary approaches, patients who have had a heart attack (particularly those with diabetes), people with peripheral artery disease and those with cardiovascular risk factors who want a comprehensive approach to heart health.

Chelation Therapy in Halifax

If you’re interested in exploring chelation therapy for cardiovascular health, Dr. Colin MacLeod ND offers comprehensive evaluation and treatment. Dr. MacLeod has been trained in the proper administration of chelation therapy and follows established safety protocols.

An initial naturopathic consultation is required before starting treatment to ensure chelation is appropriate for your individual situation and health goals. You can learn more about our chelation therapy services.

Frequently Asked Questions

Is chelation therapy a replacement for conventional heart treatments?

No. Chelation therapy should be considered a complementary approach, not a replacement for medications, procedures or lifestyle modifications recommended by your cardiologist. Always discuss any new treatments with your healthcare team.

How many treatments will I need?

For cardiovascular health benefits, most patients require 15-25 treatments. The exact number depends on individual factors including baseline toxic metal levels and cardiovascular status.

Is chelation covered by insurance?

Most extended health insurance plans in Nova Scotia cover naturopathic services, which includes chelation therapy administration. Coverage for supplies varies by plan.

How do I know if I have elevated heavy metal levels?

Testing options include blood tests for recent exposure and provoked urine challenge tests for total body burden. These can be arranged as part of your initial consultation.

References

  1. Statistics Canada. Leading causes of death, total population, by age group. Table 13-10-0394-01. 2022.
  2. Public Health Agency of Canada. Report from the Canadian Chronic Disease Surveillance System: Heart Disease in Canada, 2018.
  3. National Center for Complementary and Integrative Health. Questions and Answers: The NIH Trials of EDTA Chelation Therapy for Coronary Heart Disease. 2024.
  4. Lamas GA, Goertz C, Boineau R, et al. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013;309(12):1241-50.
  5. Escolar E, Lamas GA, Mark DB, et al. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014;7(1):15-24.
  6. Lamas GA, Ergui I. Chelation therapy to treat atherosclerosis, particularly in diabetes: is it time to reconsider? Expert Rev Cardiovasc Ther. 2016;14(8):927-938.
  7. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes. Circulation. 2014;130(25):e344-426.
  8. Lamas GA, Bhatnagar A, Jones MR, et al. Contaminant Metals as Cardiovascular Risk Factors: A Scientific Statement From the American Heart Association. J Am Heart Assoc. 2023;12(13):e029852.
  9. Navas-Acien A, Guallar E, Silbergeld EK, Rothenberg SJ. Lead exposure and cardiovascular disease: a systematic review. Environ Health Perspect. 2007;115(3):472-82.
  10. Menke A, Muntner P, Batuman V, et al. Blood lead below 0.48 micromol/L (10 microg/dL) and mortality among US adults. Circulation. 2006;114(13):1388-94.
  11. Navas-Acien A, Selvin E, Sharrett AR, et al. Lead, cadmium, smoking and increased risk of peripheral arterial disease. Circulation. 2004;109(25):3196-201.
  12. Lanphear BP, Rauch S, Auinger P, et al. Low-level lead exposure and mortality in US adults: a population-based cohort study. Lancet Public Health. 2018;3(4):e177-e184.
  13. Chowdhury R, Ramond A, O’Keeffe LM, et al. Environmental toxic metal contaminants and risk of cardiovascular disease: systematic review and meta-analysis. BMJ. 2018;362:k3310.
  14. Flora SJ, Pachauri V. Chelation in metal intoxication. Int J Environ Res Public Health. 2010;7(7):2745-88.
  15. Jomova K, Valko M. Advances in metal-induced oxidative stress and human disease. Toxicology. 2011;283(2-3):65-87.
  16. Cranton EM, Brecher A. Bypassing Bypass Surgery: Chelation Therapy: A Non-surgical Treatment for Reversing Arteriosclerosis, Improving Blocked Circulation and Slowing the Aging Process. Hampton Roads Publishing; 2001.
  17. Vaziri ND. Mechanisms of lead-induced hypertension and cardiovascular disease. Am J Physiol Heart Circ Physiol. 2008;295(2):H454-65.
  18. Ibad A, Khalid A, Ghaloo SK, et al. Chelation Therapy in Patients With Cardiovascular Disease: A Systematic Review. J Am Heart Assoc. 2022;11(5):e024648.
  19. Lamas GA, Anstrom KJ, Navas-Acien A, et al. The Trial to Assess Chelation Therapy 2 (TACT2): Rationale and design. Am Heart J. 2022;252:1-11.
  20. American College of Cardiology. TACT2: Chelation Therapy Does Not Improve Post-MI Outcomes in Patients With DM. ACC.org. 2024.
  21. Kalra S, Kim V, Lee J, et al. Exposure to Lead and Coronary Artery Atherosclerosis: A Swedish Cross-Sectional Population-Based Study. J Am Heart Assoc. 2024;13:e037633.
  22. Nawrot TS, Staessen JA, Roels HA, et al. Cadmium exposure in the population: from health risks to strategies of prevention. Biometals. 2010;23(5):769-82.
  23. Weisskopf MG, Jain N, Nie H, et al. A prospective study of bone lead concentration and death from all causes, cardiovascular diseases and cancer in the Department of Veterans Affairs Normative Aging Study. Circulation. 2009;120(12):1056-64.
  24. Ma Y, Liu Y, Wu H, et al. Cadmium exposure and cardiovascular disease risk: A systematic review and dose-response meta-analysis. Environ Pollut. 2024;343:123163.
  25. Tellez-Plaza M, Guallar E, Howard BV, et al. Cadmium exposure and incident cardiovascular disease. Epidemiology. 2013;24(3):421-9.
  26. Peters JL, Kubzansky L, McNeely E, et al. Stress as a potential modifier of the impact of lead levels on blood pressure: the normative aging study. Environ Health Perspect. 2007;115(8):1154-9.
  27. Heart and Stroke Foundation of Canada. The Changing Face of Heart Disease and Stroke in Canada. 2000.

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