A new oral drug has been found to be safe and well-tolerated in patients with chronic heart failure, according to a study led by researchers at Karolinska Institutet and published in The Lancet on June 24. The clinical trial focused on AC01, a drug designed to strengthen the heart's pumping ability through a novel biological mechanism.
Heart failure with reduced pumping capacity is characterized by the heart's inability to effectively circulate blood throughout the body. While current treatments exist, many patients experience worsening conditions over time, and existing drugs that boost heart contractions can lead to serious side effects such as disturbances in heart rhythm and changes in blood pressure.
The randomized, placebo-controlled phase 1b/2a trial involved 58 patients with stable, chronic heart failure. Participants received varying doses of AC01 or placebo for either seven or 28 days. The primary goal was to assess safety and tolerability of the drug.
Researchers reported that AC01 was well tolerated among participants. No serious side effects linked to the drug were observed, nor were there any signs of negative impacts on heart rhythm or blood pressure. Exploratory analyses suggested potential improvements in measures of cardiac function such as stroke volume and cardiac output.
“This is an early study with a limited number of patients, but the results suggest that AC01 can be administered safely to people with heart failure. The findings now justify further studies to investigate whether the signals of improved heart function that we have observed can lead to clinical benefit in larger and longer studies,” said Lars Lund, first author and professor at the Department of Medicine, Solna, Karolinska Institutet, and senior consultant cardiologist at Karolinska University Hospital.
The research was conducted collaboratively across several European countries and funded by AnaCardio AB.
