InCor initiates pioneering study with medicinal cannabis for palliative care in severe heart failure

The Heart Institute (InCor/HCFMUSP) will initiate a pioneering study to evaluate the use of medicinal cannabis in palliative care. The research focuses on patients diagnosed with severe heart failure.

The project was one of the highlights of the 3rd Call for Amendments of the Medicinal Cannabis and Industrial Hemp Parliamentary Front of the Legislative Assembly of São Paulo (Alesp). Announced this week, the initiative received R$ 330,000 for its initial operationalization.

Conducted by the Cardiac Sciences Unit of InCor, the research aims to test the efficacy of the combination of Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The main objective is to relieve symptoms in patients in the terminal stage of the disease.

According to Edimar Alcides Bocchi, director of the unit and associate professor at FMUSP, the initiative is unprecedented in medical literature. "This is an original, unique project, not found anywhere else in the world, never tested," Bocchi stated.

The specialist emphasizes the importance of the substance in treatment. "The proposal of our project is to test the efficacy of medicinal cannabis in patients with heart failure for palliative care. We believe that the combination of cannabis with other heart medications could significantly reduce suffering in this population," he added.

Disease impact and new therapies with medicinal cannabis

The choice of the target audience for treatment with medicinal cannabis reflects a critical bottleneck in public health. Heart failure is a complex syndrome in which the heart loses the ability to pump blood efficiently.

This condition is the common final pathway of most cardiovascular diseases. Moreover, it represents the leading cause of hospitalization in people over 65 years worldwide, surpassing acute myocardial infarction.

"It is the terminal disease of heart diseases and is associated with high mortality and, frequently, significant suffering," explains the professor. For many, conventional alternatives are exhausted, and heart transplantation is viable only for a minority.

In this context, palliative care comes in, focusing on preventing and relieving suffering, not just on curing. The new study at InCor seeks to verify if cannabinoids can offer this additional comfort and improve quality of life.

Research history on medicinal cannabis at InCor

InCor has already established a robust research line on the endocannabinoid system and medicinal cannabis. Among the highlights is a study published in 2024 in ESC Heart Failure, detailing the design of the ARCHER clinical trial.

This is a phase II, international, multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of CBD in 100 patients with mild to moderate acute myocarditis. Participants were treated for 12 weeks with titrated doses of 2.5 mg/kg to 10 mg/kg twice daily, accompanied by cardiac magnetic resonance imaging.

Initially, the results were not disclosed. However, in December 2025, a press release revealed a significant structural improvement in the patients' hearts, including a reduction in left ventricular mass — a finding suggesting recovery from intracellular edema.

"We conducted this study and found that cannabis can reduce one aspect of myocarditis," stated Bocchi. He also highlighted that the therapy proved to be safe and well-tolerated, with adverse events similar to those of the placebo. The study also confirmed a safety profile for the heart and liver comparable to the placebo, without the risks of serious adverse events often associated with other immunosuppressants.

Additionally, InCor is finalizing a doctoral thesis investigating the safety of isolated CBD in patients with heart failure, analyzing potential arrhythmias and the substance's effects on exercise capacity.

Next steps of the medicinal cannabis project

The new palliative care project with medicinal cannabis foresees the combined use of THC and CBD. The estimated duration is up to two years, including patient inclusion and follow-up.

The funding of R$ 330,000, coming from parliamentary amendments, will be allocated to the basic structure of the research. However, the physician emphasizes that there are still financial challenges for the full execution of the study.

"We are depending on this parliamentary amendment to continue this study, but we also need financial support for medication," explained Bocchi.

Eligible patients will be selected from the InCor database, following rigorous ethical criteria. "It is the university's role: to address scientific issues to truly provide scientific support for the use of medications to benefit patients," concluded the director.