High blood pressure is estimated to affect a large percentage of patients with pacemakers and is the primary cause of death, as it can lead to serious cardiovascular problems if left untreated or poorly controlled. At present, the only known treatment for hypertension is medication; however, the current clinical study is evaluating the efficacy and safety of a new pacemaker-based therapy. The international BACKBEAT trial involves 130 institutions worldwide and, for the time being, four institutions in Hungary, with plans to enroll a total of 316 patients.
Among European institutions, the Városmajor Heart and Vascular Center has enrolled the highest number of patients to date – 11 in total – an outstanding achievement even by international standards. “This is due to the fact that we are the largest pacemaker implantation center in Hungary. Furthermore, the continuous expansion of our clinical research activities at both the university and clinical levels is of strategic importance to us. Thanks to our active involvement in these areas, our patients have access to the latest procedures, medications, and device-based treatments among the first in the world,” said Dr. Béla Merkely, Rector of Semmelweis University and Director of the Városmajor Heart and Vascular Center. He added that building partnerships between industry and academia, as well as fostering international ties, also played an important role in enhancing scientific excellence.
“We plan to enroll pacemaker patients in the trial through the end of September who are known to have high blood pressure and continue to struggle with hypertension despite taking medication,” said Dr. István Osztheimer, Associate Professor in the center’s Department of Cardiology. The idea behind the so-called atrioventricular interval modulation therapy used in the trial is that the computer program loaded into the pacemaker alters the electrical and mechanical synchronization between the atria and ventricles in order to achieve a sustained and significant reduction in blood pressure, as explained by Dr. István Osztheimer, who, together with Dr. László Gellér, Professor at the Department of Cardiology and Head of the electrophysiology working group, is participating as an investigator in the trial led by Dr. Béla Merkely.
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All patients who come to the center for pacemaker implantation receive information about this opportunity to participate. Patients who already have a pacemaker implanted at the Városmajor Heart and Vascular Center and who meet the eligibility criteria receive personalized information from their treating physician, said Dr. István Osztheimer.
The trial is sponsored by Orchestra Biomed (OBIO), which is collaborating with the medical technology company Medtronic to make this therapy available to patients.
Pálma Dobozi
Translation: Judit Dőtsch
Photos by Boglárka Zellei, Attila Kovács – Semmelweis University
