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Don Hartz, Clinical Trial Participant

Don Hartz - Midland, MI

"There is not a bit of a downside ... I'm extremely happy that they asked me to participate and I'd do it again."

Clinical Trials Are Making Future Treatments Possible

Every medication prescribed by a physician has undergone rigorous testing through clinical trials prior to approval by the Food & Drug Administration. Without this testing, life-saving effects could not be made available to the general public. MyMichigan Health's Cardiovascular Research Department is helping to make this testing possible.

By participating in clinical research trials, volunteers like Donald Hartz of Midland help to further advancements in medical therapy and technologies.

The trial in which Donald participates in is investigating the effects of long-term treatment with a particular weight loss medication among patients who have had heart issues. He joined the trial in December 2014. So far, he has not had any cardiac-related concerns during the trial and he's lost weight. The trial is ongoing and Donald will continue to participate.

"It's been interesting," Donald said. "Since it's a double-blind study, I don't know if I'm getting the real medication or a placebo. In fact, no one knows. I take the pill twice a day as instructed."

He said he doesn't know if he's lost weight because of the pill or from changing his habits. "The real focus for me has been on my diet," Donald said. "The biggest benefit has been all of the education and help I've received."

Donald is of German heritage, and used to eat a heavy 'meat and potatoes' diet. "It's what I grew up with, and what I still enjoy," he said. "But I'm smarter now than I was two years ago and I'm definitely eating differently."

"One tool provided by the study is an online diet plan," Donald said. "I can go online at any time and enter the food that I've eaten or plan to eat and then I can read about what that means as far as calories, sodium, etc. It also gives me options – alternatives and the calorie counts, where to buy them, things like that." He said that if he entered a food item such as a rotisserie chicken from a grocery store, the program would also give him information about the advantage of home-cooked chicken.

Another part of the study requires that Donald keep an accurate record of what he eats. "At the end of the day, I enter what I've eaten that day and it gives me the total calories. I try to stay within the 1,500 – 2,000 calorie range. I don't eat as much as I used to. Age does slow the metabolism. Plus, this time of year, because I'm not as active, I don't need to eat as much."

His initial involvement in the study came about a few years after he had heart surgery. "In January 2006, I had a triple bypass surgery," Donald said. The surgery came as quite a surprise, as his cholesterol and blood pressure did not indicate a problem. However, both of his parents had similar heart problems. "I learned a lot about the heredity factor. After the surgery, I am now one of many who consults a cardiologist at least once a year."

It was his cardiologist, Interventional Cardiologist William Felten, M.D., who offered Donald the opportunity to participate in the trial. "Dr. Felten explained it all and gave me lots of information," he said. "I was very interested in the potential benefits. Most of all, if it could help people in the future, I wanted to be a part of it."

As part of the trial, Donald checks in with the Cardiovascular Research Department four times a year. "Every third visit, they run a full set of labs and do an exam to see how things are going," he said. While he never felt that his weight held him back in the past, he admits that after losing 35 pounds, he feels better. "I started at 240 pounds, and now I'd like to lose a bit more."

Donald is twice retired; once after decades with Dow Corning, then after another nine years of running his own consulting business that focused on process re-engineering. A numbers and data man by nature and occupation, he finds the trial intriguing, educational and not at all invasive or cumbersome. "This isn't the kind of study where people are peeking over my shoulder," Donald said. "They are encouraging and I found them really good to work with."

"There is not a bit of downside," Donald said. "I look at the personal benefit to me – the improved diet – and regardless of whether or not I'm taking the medicine, it's been positive for me. My cholesterol is very low, I sleep better and my wife says I no longer snore. I'm extremely happy that they asked me to participate and I’d do it again."

Health systems like MyMichigan Health are where most clinical research trials take place, as they offer one-on-one care and attention that leads to higher patient compliance. When patients stick to the requirements of a trial, longer studies can be conducted and more valuable data is collected. Clinical trials operate under strict safety guidelines. All risks must be explained to – and understood by – potential participants. They also follow a rigorous patient screening process.

MyMichigan conducts Phase II and Phase III studies, as well as outcome studies, meaning the trials involve testing drugs and treatments on larger groups of volunteers after a safe dosage and initial side effects have been identified. Registered nurse research coordinators screen MyMichigan's cardiology patients for individuals who meet specific criteria for studies and then collaborate with patients and physicians for enrollment. Patients are regularly monitored, and data is collected that helps determine the effectiveness and safety of a treatment, including any different impacts across gender and race. Through the process, which is of no cost to volunteers, patients receive frequent medical care related to the clinical trial. Those who are interested in participating in a cardiovascular clinical trial may call (989) 631-2469 or email cvresearch@mymichigan.org.

Trials currently taking place at MyMichigan Health can be viewed by going to www.clinicaltrials.gov and typing in "MyMichigan Health," or by visiting www.mymichigan.org/clinicaltrials. As everyday heroes throughout the Great Lakes Bay Region continue to participate in clinical research trials, MyMichigan Health will remain a valuable resource in the fight against heart disease and the advancement of cardiovascular treatments.

Participate in a Clinic Research Trail

To participate in Clinical Research Trial, please call our office at (989) 631-2469 or email us at cvresearch@mymichigan.org.

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