Ongoing Clinical Trials for Heart Biopsy-Related Conditions
Currently, there is one clinical trial investigating treatment options for heart inflammation confirmed through biopsy. This trial is taking place in Italy and focuses on testing an anti-inflammatory medication combined with standard immune-suppressing treatments for patients with virus-negative myocarditis.
Clinical trial locations
Study on Anakinra for Treating Virus-Negative Myocarditis in Patients
This trial is investigating a treatment approach for virus-negative myocarditis, a condition where the heart muscle becomes inflamed without a viral infection being the cause. The study tests whether adding anakinra, an anti-inflammatory medication, to standard care can improve heart function in affected patients.
Who can participate:
- Adults between 18 and 75 years old
- People with myocarditis confirmed by cardiac magnetic resonance imaging and a heart tissue test showing no virus present
- Patients whose heart’s pumping ability is below 55%, as measured by ultrasound
- Those able to understand and provide informed consent
Who cannot participate:
- Patients with other types of heart inflammation not confirmed as virus-negative
- Those who have not had an endomyocardial biopsy (a small tissue sample taken from the heart)
- People outside the specified age range
- Individuals considered part of a vulnerable population requiring special protection
What the trial involves:
The study is designed as a double-blind trial, meaning neither participants nor researchers know who receives the active medication versus placebo. All participants will receive standard care including azathioprine and prednisone, medications that suppress the immune system and reduce inflammation. Half of the participants will also receive anakinra, while the other half receives a placebo.
Anakinra is administered through subcutaneous injection, meaning it is injected under the skin. It works by blocking a specific protein called IL-1 that contributes to inflammation in the body. The goal is to see whether adding this medication to standard treatment can better reduce heart inflammation and improve the heart’s pumping ability.
The treatment period lasts six months. Throughout the study, participants undergo regular monitoring of their heart function using Trans Thoracic Echocardiography, an ultrasound test that measures how effectively the heart pumps blood. The main outcome being measured is the Left Ventricular Ejection Fraction, which indicates what percentage of blood the heart’s main pumping chamber pushes out with each beat.
Investigational medications:
Anakinra is the main medication being tested in this trial. It is an IL-1 inhibitor that reduces inflammation by blocking a specific inflammatory protein in the body. By decreasing inflammation, it may help improve heart function and reduce symptoms in patients with myocarditis.
Azathioprine is an immunosuppressive drug used as part of standard care in this trial. It works by lowering the activity of the immune system, helping prevent it from attacking the heart muscle, which reduces inflammation and potential damage.
Prednisone is a steroid medication also part of standard treatment. It reduces inflammation throughout the body and can help decrease swelling and irritation in the heart muscle, potentially leading to improved heart function and symptom relief.
Summary
Currently, only one clinical trial is actively recruiting patients for conditions diagnosed through heart biopsy. This trial is located in Italy and specifically targets patients with virus-negative myocarditis, a form of heart inflammation not caused by viral infection. The study represents an important investigation into whether adding anakinra, an anti-inflammatory medication, to existing standard treatments can provide additional benefits for heart function.
The trial focuses on a combination therapy approach, testing anakinra alongside traditional immunosuppressive medications azathioprine and prednisone. The six-month study duration allows researchers to carefully monitor changes in heart pumping ability and assess whether this treatment combination offers meaningful improvement for patients with this specific type of heart inflammation.