The active substance of red foxglove improves the prognosis of patients with heart failure
For the first time, a clinical trial has demonstrated that digitoxin—the active ingredient in digitalis, which has been used for over 200 years—improves the prognosis of patients with heart failure with reduced ejection fraction (HFrEF). Results from the 10-year DIGIT-HF study, which included over 1,200 participants, show that the drug reduces mortality and hospitalizations. The data were presented at the ESC 2025 Congress and published in the New England Journal of Medicine.
In Germany, approximately 4 million people live with heart failure. The disease is associated with shortness of breath, poor exercise tolerance, fluid retention, and arrhythmias. It is a leading cause of hospitalization and death.
Standard treatment includes beta-blockers, renin-angiotensin-aldosterone system inhibitors, diuretics, and, for several years now, SGLT-2 inhibitors. However, until now, there has been no scientific evidence confirming the effectiveness of traditional digitalis.
The DIGIT-HF study was conducted over 10 years under the direction of Prof. Johann Bauersachs and Prof. Udo Bavendiek of Hanover Medical School. The project involved over 50 centers in Germany, Austria, and Serbia, and involved 1,200 patients with advanced HFrEF despite optimal standard therapy.
The results were clear: additional digitoxin therapy reduced mortality and the number of hospitalizations for heart failure.
“We ourselves were surprised that we were able to achieve such significant improvement with additional digitoxin therapy in these very well-treated study participants,” emphasized Prof. Bauersachs.
To date, studies have focused primarily on digoxin, another cardiac glycoside. However, its use in patients with renal failure has been limited because the drug is excreted almost exclusively by the kidneys.
"The situation is different with digitoxin," explains Professor Bavendiek. This substance is metabolized primarily in the liver and intestines, so it can also be used in patients with impaired kidney function.
The study showed that, when dosed correctly, digitoxin is safe, effective and can also be used to control heart rhythm in patients with atrial fibrillation if beta-blockers are not sufficient.
What's more, digitoxin is very cheap – just a few cents per dose, making it a vital option in an era of rising treatment costs.
The currently recommended dose is 0.07 mg per day or less – instead of the 0.1 mg previously used.
“The DIGIT-HF study showed that this dose reduced mortality and hospitalizations without posing any risks,” adds Prof. Bavendiek.
Thanks to DIGIT-HF, digitoxin may become another important element of treatment for patients with HFrEF, alongside modern drugs such as SGLT-2 inhibitors.
The researchers' conclusions may soon be reflected in international guidelines.
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