National Institutes of Health awards funds for planning a second chelation study

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Sep 28, 2015, 10:13 ET

MIAMI BEACH, Fla. , Sept. 28, 2015 /PRNewswire-USNewswire/ -- The National Center for Complementary and Integrative Health (NCCIH) of the National Institutes of Health (NIH) has awarded $800,000 to Mount Sinai Medical Center of Florida and the Duke Clinical Research Institute to initiate a planning year for the second Trial to Assess Chelation Therapy (TACT2). Chelation is a process by which a medication, such as edetate disodium, can "grab" toxic metals like lead or cadmium within the body - which are present in most individuals - and allow their removal in the urine.

Dr. Gervasio Lamas, chairman of medicine and Chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center of Florida was also the study chairman in the Trial to Assess Chelation Therapy (TACT).

Planning for TACT2 follows up the positive results of TACT, an NIH-sponsored multicenter, double-blind efficacy trial, which took place from 2002- 2012 and was conducted in 134 sites across the United States and Canada. The study chairman was Dr. Gervasio Lamas, chairman of medicine and chief of the Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida. During TACT, 1,708 heart attack patients were randomized to receive 40 infusions of a 500 mL edetate disodium-based chelation solution or a placebo infusion, with a second randomization to an oral vitamin and mineral regimen or an oral placebo.

TACT demonstrated a reduction in recurrent heart events in patients who already had sustained a heart attack. Recurrent heart events measured in the study were death, heart attack, stroke, coronary revascularization and hospitalization for angina. In a sub-group of 633 diabetic patients, there was evidence of even larger benefit than seen in the overall trial, with a 41% reduction in recurrent heart events and a 43% reduction in deaths.

"A subgroup analysis of the original trial results suggests major benefit in diabetics with cardiovascular disease. The disease burden in this group of patients is devastating, so a replication of these findings is of some urgency," said Josephine P. Briggs M.D., Director of the National Center for Complementary and Integrative Health.

The TACT clinical results were presented at the American Heart Association's Scientific Sessions in 2012 and published in the Journal of the American Medical Association in 2013, Circulation: Quality and Outcomes in 2014, and the American Heart Journal in 2014.

"The hallmark of science is the ability to replicate results", said Lamas. "Therefore, in collaboration with the Duke Clinical Research Institute and NIH scientists, we are planning TACT2."

"The results of TACT were both surprising and intriguing. I am very pleased that TACT2 is building on these findings to determine if they can be replicated in diabetic patients who have experienced a myocardial infarction - a particularly high risk group of patients in need of effective therapy," said Eugene Braunwald M.D., Distinguished Hersey Professor of Medicine at Harvard Medical and Faculty Dean for Academic Programs at Partners Healthcare Systems.

Plans for TACT2 include targeting the population of patients who received the greatest benefits from edetate disodium treatment - those with a prior heart attack and diabetes. The NCCIH has approved a planning year for TACT2. If the planning phase is successful, the study team will request support for the full scale trial, in order to replicate the clinically significant results of TACT in patients with diabetes. By narrowing the patient population, TACT2's focus will be more precise and refined, allowing researchers to reduce the size, duration and cost of the trial relative to TACT.

"The excess heart disease that continues to accompany diabetes is a major public health problem with enormous human and economic costs. If the original findings in the TACT study are replicated in TACT2, we will have a new and powerful weapon to ameliorate heart disease in diabetes," said David M. Nathan, M.D., director of the Diabetes Center at Massachusetts General Hospital and a Professor of Medicine at Harvard Medical School.

The planning phase for TACT2 will include finalizing the research protocol for the trial and having it approved by the NIH. During this phase the investigators will also identify the clinical research sites that will enroll patients and finalize enrollment targets for the trial. If the implementation phase is approved, the resulting trial will pragmatically and efficiently retest the TACT results.

"Unless we can show a consistent effect across the two TACT Trials and establish a similar mechanism to deliver the treatment safely, it will be difficult for chelation to enter the mainstream of other cardiovascular therapies," Lamas said.

TACT2 planning activities will be undertaken by a study team including a clinical coordinating center led by Lamas and a data coordinating center led by Kevin J. Anstrom, PhD and Daniel B. Mark, M.D., M.P.H. from the Duke Clinical Research Institute (DCRI).

"Although not approved by the Food and Drug Administration for treating heart disease, chelation therapy has been used for nearly 60 years and has generally been believed by conventional medical practitioners and cardiologists to be without value, though TACT suggested otherwise. A definitive answer on chelation therapy that will be embraced by the cardiology community will require this additional research," said Lamas. Added Mark from the DCRI Coordinating Center, "Funding for the planning phase of TACT2 is critical, as it is the first step toward replicating what we found in TACT."

This research is supported by cooperative agreements AT9149 and AT9150 from NIH's National Center for Complementary and Integrative Health.

For more information on the planning phase of TACT2, please contact Dr. Lamas at [email protected].

About Mount Sinai Medical Center

Founded in 1949, Mount Sinai Medical Center is the largest independent, private, not-for-profit teaching hospital in South Florida. Mount Sinai's mission is to provide quality healthcare to a diverse community enhanced through teaching, research, charity care and financial responsibility. Mount Sinai's Centers of Excellence combine technology, research and academics to provide innovative and comprehensive care in cardiology, neuroscience, oncology, urology and orthopaedics. One of the original statutory teaching hospitals in the state of Florida, Mount Sinai is the hospital of choice for those who seek the level of expertise and care that only a teaching hospital can offer. Mount Sinai currently offers six convenient locations in Miami-Dade County. For more information on Mount Sinai Medical Center, visit www.msmc.com or call 305-674-CARE (2273).

About the Duke Clinical Research Institute (DCRI)

The DCRI is the largest academic research organization in the world, with a mission to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.

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SOURCE Mount Sinai Medical Center