Clinical trials help reduce illnesses, hospitalizations and death
By BECKY GILLETTE
When your life or the life of a loved one is at stake due to difficult-to-treat cardiovascular problems, you want the best possible care to prevent hospitalization and maximize quality of life. That means seeking out clinical trials that have the advantage of offering the latest, most promising treatments and interventions.
Cardiologist Frank A. McGrew, MD, director of Clinical Research at the Stern Cardiovascular Foundation, said the best clinical care is done in the setting of a research trial.
“When you are in a trial, you have a condition that isn’t completely taken care of and cured by conventional medicine,” McGrew said. “In the case of almost any cardiovascular trial, you basically will have your own private nurse to communicate with any time there are concerns. Because of that kind of care and attention in most of our trials, even patients in the placebo group will have better outcomes than the general population. We have ample evidence of that. The subjects in the trial will do better than the general population because of the opportunity to access advanced technology and medicines usually several years before they reach the general population.”
These kinds of clinical trials are not available everywhere. That leads to many cardiac patients in the region surrounding Memphis seeking treatment at the Baptist Heart Institute.
“We get a lot of patients from all over Tennessee and from Arkansas, Mississippi, Missouri, Southwest Kentucky and Northwest Alabama,” said McGrew, who also does trials for patients at Baptist Memorial Hospital in Memphis. “These research opportunities are not available anywhere else in this part of the country. We have more clinical trials than the vast majority of medical schools and university hospitals, by far.”
An example of a present trial is for people who haven’t responded to medicine for high cholesterol and have had a heart attack. People in this trial take a cholesterol medicine injection every two weeks for six months. In one trial, the new medication showed the stunning ability to cut cholesterol levels in half.
“This had a tremendous result in reducing heart attacks and deaths,” McGrew said. “Another trial we just completed of great interest to the general population was of the drug Ozempic, which was initially marketed for weight loss and diabetes. The preliminary investigations for that drug suggested it lowered cardiovascular events. In this trial called Select, the main entry criterion for patients were heart disease and obesity.”
The results, which were presented at the American Heart Association convention in November of 2023, were so impressive that many medical experts consider this one of the most important trials ever done showing significant weight loss and fewer heart attacks, strokes and deaths in non-diabetics. McGrew said people with diabetes would show even better benefits because sugar levels significantly improve.
“That is probably the most visible trial we have done in a while, a weight loss medicine that helps treat heart disease,” McGrew said.
Another trial the Stern Cardiovascular Foundation associated with Baptist Memorial Hospital in Memphis, was with a four-lead pacemaker. Pacemakers generally have one, two or three leads. A fourth lead can be put in through an artery that will strengthen the heart.
“This goes one step beyond for people who have three leads and still need an additional lead,” McGrew said. “This is added onto a small pacemaker the size of a grain of rice that is powered by ultrasound energy converted into electricity. It is unique.”
Another new device that strengthens the heart, Cardiac Contractibility Modulation (CCM), looks like a pacemaker and is inserted like a pacemaker. This new device can be combined with a defibrillator for rhythm irregularities. In addition to being used for patients with a weak heart, it can be used for patients with a stiff heart.
“That is a brand-new concept,” McGrew said. “All these trials we have talked about are not available at most large hospitals. When we can prevent hospitalizations, which we can often do with these devices, we not only help people be healthier, it saves a lot of money. We always have 30 people in the emergency room waiting for beds at Baptist Memorial Hospital. That is true of most big hospitals. If we can prevent hospitalizations, we have helped a lot of other people by freeing up those beds. And we have reduced medical costs.”
A unique thing about the Stern Cardiovascular Foundation, a 45-doctor group, is the service provided for the minorities. About 15 percent of Black Americans have Lipoprotein (a) (LPA) high cholesterol, which enhances the risk of cardiovascular disease significantly. Until recently, there was little that could be done. But now there is a trial with a self-injection pen that can be used at the first symptom of a potential heart attack. The second trial gives patients a new anti-inflammatory medicine.
“We know inflammation plays a role in heart attacks and strokes,” McGrew said. “We will identify patients at risk and give them a pill to reduce that. That whole concept will go over into arthritis and other inflammatory diseases.
“We are also paving the way with genetic analysis. Every patient in certain studies in the research department will get a genetic analysis. Another trial of tremendous importance to the general population is high blood pressure. We are doing a study now where we give a gene-modifying medicine that goes into the liver and prevents the formation of proteins that cause high blood pressure. That will be taken as an injection every six months. One of the problems with high blood pressure is that it is a silent killer. People may not know they have it and compliance with taking medicine becomes an issue because it doesn’t cause symptoms in the short run.”
McGrew said they are also involved in a study called Rebirth, a nationwide study sponsored by the National Institutes of Health to treat women who develop peripartum cardiomyopathy, a congestive heart failure late in pregnancy or within the first four months after delivery.
“To date, the only treatment for this is to use standard heart failure medications,” McGrew said. “Studies outside the United States have used a new drug, bromocriptine, which shows promise in this particular type of heart failure. This drug interferes with a naturally occurring hormone, prolactin, which is increased in pregnancy and plays a role in this type of heart failure. This trial will evaluate bromocriptine as an adjunctive agent to treat patients with this disease. Peripartum cardiomyopathy carries a very high risk of cardiac disability and even death, and often precludes successful later pregnancies.”