Orlando Heart Center | Where Every Beat Counts...

The Orlando Cardiovascular Research Institute conducts clinical trials according to Good Clinical Practice (GCP) Guidelines issued by the Food and Drug Administration (FDA) and the Code of Federal Regulations. We participate in multiple Phase II to Phase IV pharmaceutical and device trials, on both an inpatient and outpatient basis. Many of our physicians have attended Investigator GCP Training Seminars and our Study Coordinators are Certified Clinical Research Coordinators. Specific areas of interest include coronary artery disease, electrophysiology, interventional cardiology, nuclear medicine, congestive heart failure, and myocardial infarctions.

Medical Director	Robert P. Dalton MD
Research Manager	Sally Hewit, RN CCRC
Research Coordinators	Kara Work, RN Stephanie Garber, RN

RethinQ Study – assess the safety and efficacy of cardiac resynchronization therapy in patients who are indicated for implantable cardioverter defibrillation therapy.

EXACT/Guidant – compare the fast heartbeats to those generated by pacing the top part of your heart for patients who are currently implanted with the Guidant implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy with defibrillator (CRT-D)

Feasibility study – gather data to see if the EnSite System can be used to locate the area where the physician will poke one or more holes into the heart tissue.

Mend CABG II - determine the effect of MC-1 (investigational drug) on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following CABG surgery compared with placebo.

Research Highlights

Orlando Heart Center Research Department was the first site internationally to enroll a patient in the Pfizer IVUS study, as well as the top third enrolling site in the United States.

We are currently among the highest enrolling sites in the Alexion/Procter & Gamble PRIMO CABG II study.

Drugs to Help Smokers and Block Heart Attacks Show Promise

Two experimental drugs developed by biotechnology companies -- one to prevent heart attacks and the other to help people quit smoking -- have shown promising preliminary results, executives said.

One company, AtheroGenics, said yesterday that its drug for atherosclerosis had significantly reduced the volume of plaque that can clog arteries. The results, in a midstage clinical trial, sent the company's stock soaring in after-hours trading.

The other company, Nabi Biopharmaceuticals, is expected to announce today that its vaccine against nicotine helped people quit smoking in a small clinical trial.

The results of the AtheroGenics trial had been eagerly awaited because removing fatty plaque from the arteries is considered a new goal for cardiovascular drug therapy. Even the statins, the widely used anticholesterol drugs, do little if anything to reduce plaque.

AtheroGenics said its drug, AGI-1067, reduced plaque volume about 3 percent to 4 percent after a year, as measured with ultrasound. The reduction was statistically significant compared with the patients' starting levels, but not compared with the lesser reductions in patients who got a placebo.

Doctors in the trial cautioned that the preliminary results covered only 133 of about 260 patients, but nevertheless were promising.

''We want to see the final data but at the same time, I'm encouraged,'' Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, said on a company-sponsored conference call with analysts. ''It's a substantial change.''

Dr. Nissen said that while it could be misleading to compare the results of different trials, the reduction in plaque achieved by AGI-1067 was roughly equivalent to that recorded in a 47-patient trial last year using a drug developed by Esperion Therapeutics. In December, shortly after the results of Esperion's trial were announced, Pfizer agreed to pay $1.3 billion to acquire the company.

Speculation that AtheroGenics might also be acquired -- or at least will sell the rights to AGI-1067 for a large sum -- helped fuel the rise in the company's stock. The stock closed down 43 cents at $23.16 in regular trading but soared as much as 80 percent in after-hours trading.

AGI-1067, which fights the inflammation involved in heart disease, is in some sense more attractive than Esperion's drug because it is taken as a pill rather than given by intravenous infusion. AtheroGenics, based in Alpharetta, Ga., is already in a final-stage trial to determine if the drug actually does prevent heart attacks. If so, it hopes to apply by the end of next year for approval from the Food and Drug Administration.

As for Nabi's nicotine vaccine, 33 percent of those who got the highest dose quit smoking for at least 30 consecutive days compared to 9 percent who got a placebo, Dr. Henrik S. Rasmussen, Nabi's senior vice president for clinical, medical and regulatory affairs, said in an interview. Still, the trial was small, with only 68 patients, and it could not be ruled out that the difference between the vaccine and the placebo resulted from chance.

Two investigators in the trial, Dr. Stephen I. Rennard of the University of Nebraska and Dr. Dorothy Hatsukami of the University of Minnesota, called the results encouraging.

Smokers find it hard to quit because the nicotine binds to receptors in the brain and gives them a positive feeling, Dr. Rasmussen said.

The vaccine, which was given by four injections over six months in the trial, consists of nicotine connected to a detoxified bacterial protein, which, when injected, causes the body to form antibodies against nicotine. (Just injecting nicotine by itself would not elicit the antibodies.) After that, if a person smokes, the antibodies would bind to the nicotine and prevent it from reaching the brain.

''We're basically taking away the positive enforcement, which is the main reason people can't stop smoking,'' Dr. Rasmussen said.

Nabi, based in Boca Raton, Fla., will do more studies to determine the best dose and hopes to begin final-stage trials by the end of next year, Dr. Rasmussen said.

Xenova, a company based in Britain, and Cytos, based in Switzerland, are also working on nicotine vaccines, while Pfizer and Sanofi-Aventis are testing drugs that work by other means. The therapies already approved to help people quit smoking are GlaxoSmithKline's drug Zyban, and a variety of patches, gums and other products that contain nicotine, Dr. Rennard said.

Published: 09 - 28 - 2004 , Late Edition - Final , Section C , Column 3 , Page 3

By Robyn Suriano: Sentinel Staff Writer

Just walking across the room was hard for Ella Kindergan last year, when a weak heart kept her from doing almost everything. But a few months ago, she trekked around Niagara Falls on vacation while an experimental device in her chest pushed her heart to beat more strongly.

The device belongs to a new class of implants for congestive heart failure, a potentially crippling condition that affects millions of people worldwide. Many stop responding to medication, grow increasingly weak and end up house-bound. Doctors say a portion of those patients -- up to about 650,000 Americans -- are candidates for the devices...
Click for Full Article

Current Clinical Trials

ARISE Study – Reduction of vascular inflammation & coronary atherosclerosis with study drug. Reduces cardiovascular events in patients with Coronary Artery Disease.

IVUS Study – Coronary artery intravascular ultrasound evaluation of the efficacy and safety of study drug.

BREATHE Study – Evaluation of the impact of increased pacing rate in patient with sleep apnea.

CONTAK Renewal 3 AVT – Heart failure patients will receive a biventrencular device that detects and treats tachyarrhythmias.

CAPABLE: Treatment of both high blood pressure and high cholesterol in African Americans with CADUET.

PAVE Study: LV-Based Cardiac Stimulation Post AV Node Ablation Evaluation-Randomized to RV or Bi-V pacing

STRADIVARIUS – Strategy to reduce Atherosclerosis Development Involving Administration of Rimonabant- The Intravascular Ultrasound Study.

The National Institutes of Health provides a thorough explanation of how clinical trials are conducted and classified. Details for research participants are discussed at http://clinicaltrials.gov/