UF Physicians Launch Cyberspace-Aided Study To Examine Safety Of Controversial Heart Drug
GAINESVILLE—University of Florida cardiologists are at the forefront of a $30 million study that will use the Internet to determine whether a treatment strategy for high blood pressure and angina increases the risk of heart attack, stroke or death.
Physicians will compare the approach, which involves a widely prescribed class of medications called calcium antagonists, with a plan that omits these medications.
The international study is striking both for its sheer magnitude — 1,500 physicians will enroll 27,000 patients from nine countries — and because all facets of the project will be conducted in cyberspace, using a computer and the Internet to log in data and generate prescriptions.
The International Verapamil SR-Trandolapril Study, known as INVEST, seeks to show treatment based on calcium antagonists is at least as effective as standard therapy using beta-blockers and diuretics. Beta-blockers reduce the heart’s work load, slowing heart rate and reducing the force of contractions; diuretics help lower blood pressure.
Physicians have used calcium antagonists to treat high blood pressure and other heart-related ailments for more than two decades. The drugs decrease the work of the heart’s blood pumping, reduce the pressure of blood flow through the body and improve blood circulation through heart muscle.
While studies have shown verapamil SR and beta-blockers are of similar benefit for patients with the chest pain known as stable angina pectoris and for those who have suffered a heart attack, to date researchers have not put calcium antagonists to the same rigorous scientific test for patients with high blood pressure.
This past year, a Food and Drug Administration panel concluded there was no reason to discourage the use of calcium antagonists in general, despite early studies linking a short-acting form of the drug to an increased risk of heart attack or death in some patients.
“This has created tremendous controversy,” says Dr. Carl Pepine, co-director of cardiovascular medicine at UF’s College of Medicine and the study’s originator. “This is the sort of claim that can’t be defended either way because we have no direct data. The purpose of this study is to address that.”
The project is funded by Knoll AG — the originator of the first calcium antagonist, verapamil — and will take place in the United States, Canada, Germany, South Africa and several other countries. UF researchers will receive a grant of $16 million to develop and oversee the project. Knoll AG is a subsidiary of the German chemical company BASF AG.
More than 62 million Americans have high blood pressure, also known as hypertension, according to the American Heart Association. Up to half of all patients with coronary artery disease also may be hypertensive.
The study, slated to begin this summer, involves 15 regional directors selected by Pepine, the study’s principal investigator. The regional directors will identify 150 cardiologists who in turn will recommend 1,500 primary-care physicians. And those doctors, the study’s physician investigators, each will identify 15 to 20 patients — anyone 45 or older with documented high blood pressure and coronary artery disease — to participate.
“We have the ability to totally conduct this trial by electronic means, rapidly enrolling thousands of patients in four to six months and monitoring them for two years with immediate tracking of all the data ,” Pepine says. “We believe this is the way trials will be done in the future.”
Each physician participating in the study will be provided a computer configured to communicate directly with UF through the World Wide Web. This approach has the advantage of providing study data more quickly for analysis while also reducing the number of errors typically made in capturing clinical research data.
A second major feature: The computer-generated patient report becomes the official patient medical record, increasing efficiency for the physician.
All patient information will be encrypted and secured to ensure it is inaccessible to the public.