In a new study, researchers report a successful third-phase clinical trial on a new drug, which could potentially offer a new treatment for chronic heart failure.
The research was conducted by a team at the University of Alberta.
The VICTORIA (Vericiguat Global Study In Subjects With Heart Failure With Reduced Ejection Fraction) clinical trial examined the effects of a drug called vericiguat on patients at a high risk of death or hospitalization from heart failure.
Over nearly four years, the VICTORIA trial enrolled more than 5,000 patients at 600 centers across 42 countries, including 145 Canadian patients with chronic heart failure that included low ejection fractions.
In the Phase III clinical trial, half of the participants were randomly selected to receive vericiguat in combination with standard heart failure therapy. The other half received standard treatment and a placebo drug.
The results showed that rates of cardiovascular death or hospitalization among the patients who received vericiguat were 10% lower than the rates among the placebo group.
This was clinically meaningful because it meant an absolute reduction in negative health events in 4.2% of patients already receiving optimal heart failure care.
Along with reducing cardiovascular death and hospitalization in patients, vericiguat was also found to have few side-effects, and positive effects as early as three months into the trial.
It was the first large study to focus exclusively on the condition, and to specifically evaluate those with a low proportion of blood being pumped out of their hearts, a measure called ejection fraction.
According to the team, vericiguat works by stimulating an enzyme in the body called soluble guanylate cyclase (sGC), which is important for enhancing heart function and helping blood vessels relax to provide better blood flow.
In patients with heart failure, sGC is reduced and unable to adequately stimulate cyclic guanosine monophosphate (cGMP), necessary for transmitting chemical signals to blood vessels, which results in vascular and coronary dysfunction.
Vericiguat is the first drug of its kind to be investigated as a once-daily oral treatment for patients with worsening chronic heart failure.
The team says patients with heart failure who have just been hospitalized are at the greatest risk of death or readmission to the hospital.
With the successful completion of the Phase III trial of vericiguat, the trial co-sponsors Merck & Co, Inc. and Bayer AG expect to share the study results with regulatory agencies around the world.
A separate study is also underway to test whether vericiguat offers benefits for those with heart failure with preserved ejection fraction, a different form of the disease for which there are even fewer treatment options available.
The lead author of the study is U of A distinguished professor of medicine Paul Armstrong.
The study is published in the New England Journal of Medicine.
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