Beta3_LVH: towards a treatment against heart failure

How is the study carried out?

The management of the project takes place at different levels: 

• UCL: as a sponsor, coordinates and manages the project

• UNI-Leipzig: oversees the trial

• ECRIN-ERIC: ensures the monitoring of sites in different countries

• ESC: considers all safety issues

What kind of exam will be performed?

The assessment of the change in diastolic function and LV mass index includes:

• an echocardiography 

• an MRI 

The exams for the 2 substudies are: 

• a blood sample for the study of the endothelial function

• a PET scan for the study of the change in the brown fat tissue

What is the placebo effect?

Check out the answer here.

What are the risks vs benefits?

Potential benefits are:

• You might help others having the same condition by helping to advance research.

• You could have access to treatment that’s not otherwise available.

• You may increase the total number of treatment options available to you, even if you haven’t had all of the standard treatments.

• You may feel you have more control over your situation and are taking a more active role in your health care.

• You’ll probably get more attention from your health care team and more careful monitoring of your condition and the possible side effects of treatment if you take part in a clinical trial. 

Potential risks are: 

• The new treatment may have unknown side effects or other risks. 

• As with other forms of therapy, the new treatment may not work for you even if it helps others.

• There may be inconveniences such as more frequent office visits and testing, as well as time and travel commitments.

• As you take part in a randomized clinical trial, you have no choice about which treatment you get. As the study is blind, you and your doctor will not know which treatment you will be getting (although this information is available if needed for your safety). This will be explained to you before you decide to take part. 

Are patients paid for entering the study?

No, patients are not paid for entering the trial.

However, the study sponsor provides the new treatment at no cost and pays for all special tests, procedures, and extra doctor visits.  

How long will the study last?

The study will last 1 year.

During that year the patients will have to take the assigned drug once a day and go to the hospital for examinations and procedures 4 times in the year at 1, 6, 9, 12 months after enrolment.