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.
Who is the sponsor?
This is a Horizon 2020 project funded by the european union involving european academic partners. The Beta3_LVH project is initiated by the Université catholique de Louvain who is the sponsor of this trial.
Who are the partners?
The project Beta3_LVH gathers 12 partners in 8 european countries. Several key members are identified in each country:
UCL: Prof. Jean-Luc Balligand
CUSL: Prof Anne-Catherine Pouleur; Prof Alexandre Persu; Prof Bernhard Gerber; Dr Renaud Lhommel; Dr Damien Gruson
Poland (UMW): Piotr Ponikowski; Ewa A. Jankowska
Portugal (AIDFM): Prof. Fausto J. Pinto; Prof. Dulce Brito; Prof. Ana G. Almeida
Cardiovascular medicine: Prof. Barbara Casadei
Clinical magnetic resonance: Prof Stefan Neubauer; Dr. Masliza Mahmod; Dr Stefan Piechnik
CHU Nantes: Dr. Jean-Noël Trochu; Dr. Nicolas Piriou
ESC: Prof Dr. Stefan D. Anker
UMG-GOE: Dr. Rolf Wachter; Dr. F. Edelmann
Charité: Prof. Burkert Pieske; Dr. Elisabeth Pieske-Krainer
UNI-Leipzig:Dr. Oana Brosteanu; Prof. Dr. Markus Löffler; Dr Petra Neuhous
ECRIN-ERIC: Anke Strenge Hesse; Jacques Demotes
Italy (HPG23): Prof Dr. Michele Senni; Dr. Antonello Gavazzi; Marilisa Ambrosio
Greece (NKUA): Prof. John Lekakis; Prof. Gerasimos Filippatos; Dr. Dimitrios Farmakis; Dr Ignatios Ikonomidis
Where are the partners located?
The project Beta3_LVH gathers 12 partners in 8 european countries: