Researchers at Mount Sinai Medical Center of Florida and the Duke Clinical Research Institute received $37 million from the National Institutes of Health (NIH) to begin the second phase of the Trial to Assess Chelation Therapy (TACT2).
The initial TACT trial enrolled patients at 134 sites in the U.S. and Canada from 2002 to 2012. During the study, researchers randomly assigned 1,708 patients who suffered an MI to receive 40 infusions of an edetate disodium-based chelation solution or a placebo infusion.
The composite primary endpoint of death from any cause, reinfarction, stroke, coronary revascularization or hospitalization for angina occurred in 26 percent of patients in the chelation group and 30 percent of patients in the placebo group. When the results were published in the JAMA in March 2013, researchers mentioned several issues with the trial, including that only 65 percent of enrollees completed 40 infusions and 76 percent completed at least 30.
The FDA has not approved chelation therapy to treat heart disease.
The TACT2 researchers plan on enrolling 1,200 patients with diabetes who are at least 50 years old and survived an MI, which was the group that most benefited from chelation therapy in the original TACT study. Patients will receive intravenous chelation treatments as well as oral vitamins. The researchers are interested in determining if the treatment regimen reduces recurrent MI, stroke, death and other heart episodes.
Researchers already have conducted a one-year planning phase for TACT2, finalized the research protocol, gained NIH approval and identified more than 100 research sites in the U.S. and Canada.
The NIH’s National Center for Complementary and Integrative Health awarded the $37 million for the trial. Researchers have also received funding from the National Heart, Lung and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Environmental Health Sciences.
“The results of the original TACT study suggested that chelation of toxic environmentally-acquired metals may reduce cardiac risk, particularly in diabetic patients,” Valentin Fuster, MD, PhD, physician-in-chief for Mount Sinai Hospital in New York and director of Mount Sinai Heart, said in a news release. “If a second TACT study (TACT2) can confirm these interesting and relevant findings, it has great potential to change cardiac therapeutics.”