Studying a drug to prevent heart attacks
Heart disease is the number-one cause of death in America, accounting for 1 in 4 deaths in a normal year. According to the CDC, before the pandemic about 659,000 Americans died from heart disease each year.
Many of us know someone who has had a heart attack or takes medication to prevent one. Common heart disease medications include statins, beta-blockers, diuretics and ACE inhibitors.
Now, researchers at NIH’s National Heart, Lung and Blood Institute are testing a new drug that may help remove excess cholesterol — a major cause of heart attack — from arteries.
In a phase 1 trial this year, they’re testing that drug, which may also be used for asthma, colitis and kidney disease, to see if it’s safe in healthy individuals.
According to NIH, “Models have shown that Fx-5A can minimize inflammation associated with diseases like asthma, colitis and chronic kidney disease. This study will evaluate how well [participants] tolerate a single dose of Fx-5A when given through an IV and how safe it is to use in healthy individuals.”
Four visits, one overnight
The study lasts five to 10 weeks, and people who enroll will make four visits to the NIH campus in Bethesda, Maryland.
At the first visit, participants will spend a few hours at NIH to give blood and take several tests.
During the second visit, participants will receive a single dose of the drug, Fx-5A, by IV and remain in the NIH clinical center for up to two days. (They will be compensated for their time.)
“We try to make their stay as pleasurable as possible,” said Marcelo J. Amar, M.D., of the National Heart, Lung and Blood Institute, the study’s principal investigator.
“I want them to be interested in the study,” he said. “They’ll get to know more about themselves and their health.”
After the overnight stay, participants will have two short follow-up visits one week and one month later. At these visits, they will give blood and have an electrocardiogram (EKG), a painless test that takes a few minutes.
Healthy people over 18 are welcome to participate as long as they don’t take any medications, vitamins or supplements for eight weeks prior to the study and four weeks after the study ends.
Hope for the future
After this Phase I study of the investigational drug ends, researchers will design a larger clinical trial to test Fx-5A.
Because previous studies showed the drug reduced plaque in the arteries, scientists are cautiously optimistic about the drug’s potential to save lives.
“It’s something that could potentially help a lot of people … and people like to have that feeling of helping other people,” Amar said.
In addition, NIH will compensate participants a maximum of $1,500 for completing the study.
For more information, call 1-800-411-1222 or (301) 451-4383 or email PRPL@cc.nih.gov.