Enrollment Resumes for CHD Chelation-Therapy Trial

June 12, 2009

June 12, 2009 (Bethesda, Maryland) — A controversial trial of chelation therapy for patients with a history of MI, which halted enrollment last year after high-profile questions were raised about its ethicality, has started taking patients again, the Associated Press (AP) is reporting [1].

Meanwhile, an investigation continues into, among other issues, allegations that patients in the study, called the Trial to Assess Chelation Therapy (TACT), were inadequately informed about the treatment's risks, notes the story from AP medical reporter Marilynn Marchione.

As covered at the time by heartwire, the Office for Human Research Protections of the US Department Health and Human Services launched its investigation of TACT in August 2008, after publication of an article in a peer-reviewed journal that also charged that some of the investigators had financial stakes in the very treatment they were studying [2].

At the time of its suspension last year, the double-blind TACT trial had randomized about 1500 patients (out of the >2400 planned) to receive placebo or chelation therapy consisting of injections of ethylene-diamine-tetra-acetic acid (EDTA).

Enrollment in the trial, with sponsorship from both the National Heart, Lung, and Blood Institute and the National Center for Complementary and Alternative Medicine, had been proceeding slower than expected.

The 2008 article critical of the TACT trial was published by the Medscape Journal of Medicine, which is owned by WebMD, also the owner of theheart.org.

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