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Clinical trial at Florida Hospital seeks new heart failure treatment

In the Florida Hospital Pepin Heart Institute’s cardiac catheterization lab, Dr. Leslie Miller, left, confirms the spot for Dr. Charles Lambert, far right, to manipulate the catheter tip as Larry Lobacz of device maker BioCardia, lower left, draws an injection map of gene therapy delivery sites in the heart.

DANIEL W. BAKER | Special to the Times

In the Florida Hospital Pepin Heart Institute’s cardiac catheterization lab, Dr. Leslie Miller, left, confirms the spot for Dr. Charles Lambert, far right, to manipulate the catheter tip as Larry Lobacz of device maker BioCardia, lower left, draws an injection map of gene therapy delivery sites in the heart.


Anthony Maruca understands the value of research. He worked on experimental engineering projects for most of his professional career, some of them top secret, designing and building jet engines and fuel cells used by NASA, the U.S. military and commercial clients such as Boeing. Now at age 81, Maruca's interest in research is more personal than ever.

Last month, Maruca joined a nationwide clinical trial that is testing a unique approach to healing damaged heart tissue. If it works, thousands of Americans suffering from congestive heart failure stand to benefit, Maruca among them. He has had the condition for about two years. "You get very tired with it, and you can't walk any distance," said the retiree, who lives in Inverness.

The trial, known as the STOP-HF trial, will enroll patients at 10 U.S. medical centers including Florida Hospital Pepin Heart Institute and USF Health. At least 10 patients will be enrolled from the Tampa Bay area, possibly more. "We'll take as many as we can get," said Dr. Charles Lambert, medical director at Pepin.

STOP-HF is one of several clinical trials in which Pepin is collaborating with the newly formed USF Heart Institute led by Dr. Leslie Miller, who is lead investigator on the heart failure trial.

Miller came to Tampa two years ago to start a cardiac research and treatment program focusing on the emerging field of regenerative medicine. Simply stated, the concept is to use specially manufactured genes that control the heart's ability to pump blood or the body's own stem cells to heal and grow healthy tissue and blood vessels in areas of the body where tissue is badly damaged or dead.

The STOP-HF trial uses a gene therapy drug called JVS-100, injected directly into the heart. Researchers believe that in the heart muscle, JVS-100 directs the heart to produce a protein that attracts stem cells to the heart like a magnet. The stem cells have been shown to work like an internal repair system to mend damaged tissue, grow new blood vessels and prevent further damage to the heart. "This is exactly what I envisioned and it's great to see this launched," said Miller. "I believe that this will be the future of cardiovascular therapy."

A year ago this month USF announced the formation of a formal partnership with Pepin to advance USF's cardiac research goals. Since then the two institutions have collaborated on several clinical trials and the training of residents and cardiology fellows.

Miller said Pepin has a well established team of research personnel who can coordinate all aspects of a clinical trial. "It was an easy process to work with what was already in place there," said Miller. "Plus there was the opportunity to work with Dr. Lambert who has lots of experience with the direct delivery of stem cells into the heart.''

Lambert is the interventional cardiologist for the STOP-HF trial, and a professor at USF Health who mentors physicians seeking advanced training in cardiology. He also is a professor at the University of Florida college of medicine.

To participate in the study, patients must meet a number of requirements, including significant difficulty with physical exertion despite treatment and must have an implanted defibrillator. Patients will be followed for at least a year. "The most sensitive thing you can measure is how you improve exercise tolerance. We'll look at a number of factors, but the bottom line is how well their hearts pump and how well they can exercise," said Lambert.

Not all patients who volunteer for the study will get the gene therapy, because it's not possible to know whether the treatment works better than the current standard of care if there is no comparison group.

Maruca had an injection on Feb. 12. The procedure took about two hours and he spent one night in the hospital and went home the next morning.

"If anything I feel a little more tired than before," he said after the procedure. Miller said Wednesday that Maruca is doing well, heart-wise, though he's recovering from health issues unrelated to the trial.

Doctors say it could take a few months for patients who received the treatment to show improvement, but it will be much longer before the results of the clinical trial are known.

Clinical trial at Florida Hospital seeks new heart failure treatment 03/06/13 [Last modified: Wednesday, March 6, 2013 8:49pm]
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