Chris Hatlestad, a Bend doctor, was the only Oregon physician selected last month to contribute to a national study on using a treatment for lead poisoning to help patients with heart disease.

The 5-year, $30 million Trial to Assess Chelation Therapy was launched last September by the National Institutes of Health (NIH). The project aims to measure the safety and effectiveness of chelation therapy – a commonly prescribed treatment for lead poisoning – in patients with coronary artery disease.

This study is not Hatlestad’s first foray into chelation therapy research.

For almost a year now, Hatlestad has been conducting a local study with St. Charles Medical Center-Bend, testing a theory of how chelation therapy actually works.

Chelation therapy is a method of removing certain metals and minerals from the blood. It has been approved by the U.S. Food and Drug Administration (FDA) as a safe, effective treatment for heavy metal toxicity, such as lead poisoning. It has not been approved as a treatment for heart disease.

Hatlestad, a primary care physician who specializes in a combination of conventional and alternative treatments, offers the therapy to patients with heavy metal poisoning and to those with coronary artery disease.

It is legal to prescribe an approved medication or treatment for unapproved uses, Hatlestad said.

For example, doctors frequently prescribe certain types of anti-depressants as pain medication, Hatlestad said, even though they are approved by the FDA as anti-depressants only, and not for treating pain.

Hatlestad said, so far, all he has is anecdotal evidence to support the chelation treatment.

”I’ve seen people with vascular disease who have had symptomatic relief by doing chelation therapy,” Hatlestad said. ”We want to try to legitimize chelation therapy or disprove it.”

Hatlestad’s approach to medicine is visible all over his private practice, which, at first glance, looks like any doctor’s office near St. Charles Medical Center-Bend.

But Hatlestad, 43, walks around in casual clothing and no lab coat.

He slips off his shoes and pads around in socks. His dog, Panik, quietly stretches out on the floor of his office. On the shelves above his desk, medical dictionaries are stacked next to books like ”Accu-Yoga” and ”Healing with Whole Foods.”

The NIH study will involve 2,372 patients at more than 100 research sites across the country. It is more than 20 times larger than any previous study of the treatment, according to NIH.

Dr. Stephen Straus, director of the NIH Center for Complementary and Alternative Medicine, said in a statement that the study was necessary because chelation therapy is widely prescribed to treat heart disease, yet little research has been done on its safety or effectiveness.

Coronary artery disease is the most common form of heart disease and the leading cause of death for men and women in the United States, according to NIH.

Coronary arteries are the vessels that bring oxygen-rich blood into the heart. In a patient with the disease, these vessels become blocked by a fatty substance called plaque. As plaque builds, the arteries become narrower, allowing less blood to reach the heart.

If too little oxygen reaches the heart, the patient could experience chest pain or a heart attack. In a heart attack, oxygen deprivation actually causes part of the heart muscle to die. If a large portion of the heart is affected, it can cause chronic heart failure or death.

According to NIH, a person with the disease may exhibit symptoms including chest pain, shortness of breath, lightheadedness, cold sweats or nausea.

Scientists are still learning about what causes the disease, Hatlestad said. Certain factors are known to increase the risk of the disease, including high blood pressure, high cholesterol, smoking, obesity, physical inactivity, diabetes and a family history of the disease.

”The important thing is that vascular disease has several risk factors involved, and they’re probably not the same from one patient to the next,” Hatlestad said. ”So you and I could eat the same things and have the same blood pressure, but still have different risk factors.”

”Those could involve genetics, or they could have to do with different environmental conditions that we are exposed to,” he continued.

”If you are taking birth control pills, for example, that could affect your B-vitamin status, and that could affect your risk for heart disease.”

In chelation therapy, a patient receives an intravenous transfusion of ethylene diamine tetra-acetic acid (EDTA). This substance speeds up the removal of heavy metals and minerals such as lead, iron, copper and calcium from the blood.

EDTA binds to elements in the blood, and the elements are then excreted in the patient’s urine or feces.

Doctors are still not sure exactly how chelation therapy works, but they have several theories, Hatlestad said. The NIH study aims to help doctors understand if – not how – the treatment works.

Answering the other question comprises the goal of a local study, currently being conducted on 20 patients in Central Oregon. Participants in that study suffer from coronary artery disease and have been undergoing chelation therapy for almost a year, Hatlestad said.

Before they started the treatment, each patient underwent a scanning process to determine how much plaque had built up in their arteries.

After they have completed a year of treatment, they will be re-scanned, and the results will be compared, he said.

That study is designed to test one theory that chelation therapy works by removing calcium – a main component of the plaque that blocks arteries. In that theory, it would essentially clean out the arteries and reduce symptoms, Hatlestad said.

Chelation therapy was first used in the 1940s for the treatment of heavy metal poisoning, and in the 1950s for the treatment of coronary artery disease, Hatlestad said.

According to Hatlestad, the therapy has only a few minor side effects, including dizziness and fatigue for about a day following the transfusion.

”But it’s been pretty controversial,” he added. ”And there haven’t been very many good studies on it.”

Participants in the NIH study will be randomly assigned to one of two groups.

One will receive a standardized chelation solution. One will receive a placebo solution. Those two groups will also be randomly divided to receive high or low dose vitamin and mineral supplements.

The effectiveness of the supplements, as part of the chelation therapy, is also a topic of study, Hatlestad said.

Each participant will receive 30 weekly infusions, followed by 10 bimonthly infusions, he said. All patients enrolled will be followed until the end of the study, to observe any significant clinical benefits or side effects.

Hatlestad said he expects to enroll 20 or 30 local patients in the study. Participants must be over 50 years old, and must have had a heart attack. If selected to participate, they will receive one year of free treatment.

Hatlestad said he currently administers chelation therapy to between 60 and 80 patients. He said that some of his patients with coronary artery disease have experienced a return of symptoms after completing chelation therapy.

”What we don’t know is, would it have happened sooner without the chelation therapy? Would it have happened anyway? And that’s why we’re doing this study, to try to answer those questions,” he said.

Lily Raff can be reached at 541-617-7836 or lraff@bendbulletin.com.