Good results in trials of a new treatment for heart failure

A new trial has confirmed the benefits of a drug, finerenone, in a significant segment of heart failure cases.

This is a study with more than 6,000 patients from 37 countries, which in Spain has been coordinated by the Heart Disease Department of the Bellvitge Hospital, in Hospitalet de Llobregat, Barcelona.

Specifically, the international FINEARTS-HF trial has confirmed for the first time that fineronone, a drug that until now is prescribed in certain cases of chronic kidney disease, reduces the worsening and increases the survival of patients with heart failure with an ejection fraction (percentage of blood that the left ventricle pumps into the aorta in each contraction) of 40% or more. This may lead to a change in clinical guidelines for the treatment of nearly 50% of people with heart failure.

This segment of heart failure patients has so far had no therapeutic solution other than sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors), which have only a partial effect. “The results of this study represent an unprecedented advance in the management of patients with heart failure and preserved ventricular function, since until now the therapeutic options for them were very limited,” according to Dr. Josep Comin, coordinator of the trial in Spain, the country that has contributed the most patients to the study after the United States and China.

Dr. Comin is clinical director of the Heart Disease Area of ​​Bellvitge Hospital (HUB) and of the Bio-Heart Cardiovascular Disease Research Group of the Bellvitge Biomedical Research Institute (IDIBELL) and the Biomedical Research Network Center for Cardiovascular Diseases (CIBERCV), in Spain.

Bellvitge Hospital has co-led the international trial on finerenone. (Photo: Bellvitge Hospital)

Heart failure is a chronic disease characterized by the progressive decrease in the heart’s ability to fill and pump enough blood to meet the body’s needs. It affects around 208,000 people in Catalonia and more than 60 million people worldwide. In 2023, 37,000 new cases were diagnosed in Catalonia and more than 400,000 emergency room visits and hospitalizations were recorded.

One of the parameters for diagnosing heart failure in a person is the percentage of blood that the left ventricle pumps into the aorta with each contraction. This is called the ejection fraction and depending on the percentage, it is considered normal (between 50% and 70%), slightly reduced (between 41% and 49%) and reduced (less than 40%).

The multicenter Phase III study, sponsored by Bayer and led by Dr. Scott Solomon of Harvard University in the United States and Dr. John V. McMurray of the University of Glasgow in the United Kingdom, involved more than 6,000 patients from centers in 37 countries around the world. Patients were followed for an average of 32 months. Patients were divided between the group that received the drug and the group that received a placebo.

Fineronone belongs to a group of drugs called mineralocorticoid receptor antagonists (MRAs), which block the activity of certain steroids produced by the human body that can cause damage to the heart and kidneys.

According to the results of the trial, administration of fineronone reduced the risk of cardiovascular death and episodes of heart failure requiring hospitalization by about 16% compared to patients included in the group that received a placebo. For this reason, Dr. Comin concludes that “the contributions of the FINEARTS-HF study will undoubtedly imply a change in international clinical practice guidelines for the management of heart failure.”

The results of the trial were recently presented in London at the Congress of the European Society of Cardiology, coinciding with the publication in the academic journal New England Journal of Medicine, under the title “Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction”. (Source: Bellvitge Hospital)