May 30, 2003

VUMC receives top international ranking for heart transplant trial

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Dr. Stacy Davis examines transplant patient Charles Anderson of La Vergne, Tenn. Anderson, who is not a participant in the current study, underwent a heart transplant nine years ago at age 13. (photo by Dana Johnson)

VUMC receives top international ranking for heart transplant trial

Vanderbilt University Medical Center has been ranked No. 3 worldwide in enrollment for an international trial testing the efficacy of a new immunosuppressant drug for use in heart transplant patients.

Dr. Stacy F. Davis, assistant professor of Medicine, is the primary investigator for the Vanderbilt study.

The study, sponsored by Novartis, is a randomized, single blind trial testing a known immunosuppressant therapy called Mycophenolate Mofetil (MMF) against a newer more tolerant form called Mycophenolic Acid (ERL).

The standard therapy may cause significant nausea and gastrointestinal distress. The hope is that the newer drug, a broken-down formulation of the existing therapy, will be better tolerated. Investigators already have some evidence that it is just as effective.

“We are always working to bring new medications to patients,” Davis said. “Transplant is founded on clinical trials. When it comes to immunosuppressive therapy, patients must have options. We are always searching for the medications that do the best job with fewer side effects. Quality of life is important.”

The trial, which includes a total of 153 patients, is only available at eight U.S. sites, 28 worldwide. Vanderbilt recently closed its enrollment after attaining its goal of 12 patients.

Designed as a 12-month core study with a 12-month extension, patients are allowed to withdraw at any time.

“One of the biggest advantages of being on such a study is the ability of patients to have access to a wider variety of medications sooner,” Davis said. “This is one of the main reasons patients enroll in immunosuppressant trials. But the other reason is this is a way patients feel that they can help others. We see it over and over again. Oftentimes they tell us ‘if I can help others through this experience I will, because someone came before me.’”

Davis attributes the Vanderbilt enrollment success to the wonderful team of research nurses who are very “detail-oriented and patient-focused,” she said.

Kristi Hanley, R.N., research coordinator, said it’s easier to be successful when patients enter medical environments like Vanderbilt expecting innovative services and treatments.

“This type of study is really a win-win situation,” Hanley said. “Our patients are willing to have a level of uncertainty in order to have the opportunity to try a new formulation of a proven therapy.

“Some of our patients don’t see it as a big deal, while others are always asking questions and want information about the entire study.”

All patients enrolled in the study are first-time transplant patients who met certain criteria including the absence of elevated antibody levels pre-transplant and the ability to take oral medications within the first three days post surgery.