(Press-News.org) Sophia Antipolis – 21 November 2023: The first clinical trial to challenge the routine implantation of a defibrillator in myocardial infarction survivors with heart failure has enrolled its first patient. The PROFID EHRA trial is part of the EU-funded PROFID project, which aims to personalise the prevention of sudden cardiac death after myocardial infarction and involves a consortium of 21 multidisciplinary partners including the European Society of Cardiology (ESC).
Sudden cardiac death is a major public health problem responsible for approximately one in five fatalities in Europe. Most sudden cardiac deaths occur in myocardial infarction survivors. To prevent these deaths, patients whose heart pumps less well than it should following a heart attack currently receive an implantable cardioverter defibrillator (ICD). However, modern drug treatments have been shown to lower the risk of sudden death in these patients, thereby reducing the need for life-saving ICD shocks.1-5
Dr. Nikolaos Dagres, chief investigator of the trial, said: “The PROFID EHRA trial is set to influence clinical practice around the world by closing a huge evidence gap that has existed for the past 20 years. The trial is re-evaluating the role of ICD implantation in post-myocardial infarction patients in the context of contemporary medical treatment and will provide vital new information to optimally guide therapy and address this serious health issue.”
The study will test whether in post-myocardial infarction patients with symptomatic heart failure and reduced left ventricular ejection fraction (35% or less) drug treatment alone is not inferior to drug treatment plus an ICD for preventing sudden death in heart attack survivors with heart failure and a reduced pump function.
Professor Gerhard Hindricks, chief investigator of the trial, said: “PROFID EHRA is a ground-breaking study that could change the prevention of sudden cardiac death in clinical practice. Currently, many patients who receive an ICD never need one, while some who could benefit miss out. This trial will provide novel, randomised evidence on which patients should receive a defibrillator, and which patients can be spared an unnecessary procedure which typically requires an overnight stay in hospital and may lead to complications or unintended shocks from the device.”
The trial will recruit some 3,595 patients from 180 hospitals in 13 countries – namely Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Poland, Spain, Sweden, the Netherlands, and the UK. The first patient was enrolled from the Heart Centre Segeberger Kliniken in Germany.
Participants are being randomly allocated to 1) optimal medical therapy alone or 2) optimal medical therapy plus ICD implantation. Participants will be followed up for around 2.5 years for the primary outcome of all-cause death. The investigators will also examine the impact of the two treatment strategies on death from cardiovascular causes, sudden cardiac death, hospital readmissions for cardiovascular causes, length of stay in hospital, quality of life, and cost effectiveness. The study is due to last for approximately 49 months, with results expected in early 2027.
Professor Jose L. Merino, EHRA president and national coordinator of the PROFID EHRA trial in Spain, said: “The PROFID EHRA trial is set to redefine the use of ICDs in myocardial infarction survivors, and is therefore a very important scientific study for the European Heart Rhythm Association (EHRA) and for clinical practice globally.”
Notes to editors
Authors: ESC Press Office
Mobile: +336 61 40 18 84
Follow us on Twitter @ESCardioNews
Funding: PROFID has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 847999.
References and notes
1Desai AS, McMurray JJV, Packer M, et al. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J. 2015;36:1990-1997.
2Pitt B, Gheorghiade M, Zannad F, et al. Evaluation of eplerenone in the subgroup of EPHESUS pa-tients with baseline left ventricular ejection fraction ≤30%. Eur J Heart Fail. 2006;8:295-301.
3McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381:1995-2008.
4Packer M, Anker SD, Butler J, et al. Cardiovascular and renal outcomes with empagliflozin in heart failure. N Engl J Med. 2020;383:1413-1424.
5Sabbag A, Suleiman M, Laish-Farkash A, et al. Contemporary rates of appropriate shock therapy in patients who receive implantable device therapy in a real-world setting: From the Israeli ICD Registry. Heart Rhythm. 2015;12:2426-2433.
About the European Heart Rhythm Association
The European Heart Rhythm Association (EHRA) is a branch of the European Society of Cardiology (ESC). Its aim is to improve patients’ quality of life and reduce sudden cardiac death by limiting the impact of heart rhythm disturbances.
About the European Society of Cardiology
The European Society of Cardiology brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people lead longer, healthier lives.
Trial to prevent sudden death after a heart attack enrols first patient
ELSE PRESS RELEASES FROM THIS DATE:
High temperatures may have caused over 70,000 excess deaths in Europe in 2022
The burden of heat-related mortality during the summer of 2022 in Europe may have exceeded 70,000 deaths according to a study led by the Barcelona Institute for Global Health (ISGlobal), a research centre supported by the “la Caixa” Foundation. The authors of the study, published in The Lancet Regional Health – Europe, revised upwards initial estimates of the mortality associated with record temperatures in 2022 on the European continent. In an earlier study, published in Nature Medicine, the same team used epidemiological models applied to weekly temperature and mortality data in 823 regions in 35 European countries and estimated the number ...
Toward sustainable energy applications with breakthrough in proton conductors
Donor doping into a mother material with disordered intrinsic oxygen vacancies, instead of the widely used strategy of acceptor doping into a material without oxygen vacancies, can greatly enhance the conductivity and stability of perovskite-type proton conductors at intermediate and low temperatures of 250–400 °C, as demonstrated by Tokyo Tech scientists (e.g. 10 mS/cm at 320 °C). This innovative approach provides a new design direction for proton conductors for fuel cells and electrolysis cells. Many countries in the world are pushing for the development ...
Apology psychology: Breaking gender stereotypes leads to more effective communication
Saying "I'm sorry," especially in the workplace, can be tricky terrain. Delivering an effective apology can help resolve conflicts, restore trust and promote collaboration among coworkers. But what works best? A research team including a University of Arizona faculty member says that to make your next apology more effective, use language that goes against gender stereotypes. Sarah Doyle, associate professor in the Department of Management and Organizations in the Eller College of Management, said the team wanted to ...
Poor nutrition contributes to poor mental health and risk of diabetes
People with diabetes (Diabetes Mellitus) are two-to-three times more likely to have depression than people without, according to the Centers for Disease Control. Current treatment includes therapy, medicine, or both. However, the understanding of the multifaceted relationship between nutrition, mental health, and DM is relatively new in scientific discourse. Mason researchers sought to learn about the connection between nutrition, diabetes, and mental health. Two literature reviews from assistant ...
Ochsner participates in study showing aspirin may not be necessary with LVAD
A groundbreaking study recently published in JAMA indicates that aspirin may not be necessary as part of an antithrombotic regimen for patients with a fully magnetically levitated left ventricular assist device (LVAD). Ochsner Health surgical director for the Mechanical Assist Device Circulatory Support Program, Dr. Aditya Bansal, was a contributing author on the study known as the ARIES-HM3 trial. The ARIES-HM3 trial, a randomized trial involving 628 patients with advanced heart failure, compared the outcomes of patients who received aspirin (100 mg/d) with those who received a placebo in addition to a vitamin K antagonist ...
Caring is sharing: Call for more openness on cancer drug trial results
Development of potential or improved anti-cancer treatments are being blocked or slowed down by lack of transparency in data sharing between pharmaceutical companies and research groups, according to cancer clinicians, researchers and consumers. The multidisciplinary team led by Flinders University researchers Mr Natansh Modi and Dr Ashley Hopkins evaluates the literature and policy developments since the 2013 data sharing commitments were struck by US and European regulators, including the commitment to publish clinical trial results. The agreement forged by the Pharmaceutical Research and Manufacturers ...
Calls for improved support about menstruation changes during perimenopause
Perimenopausal women need better education and support about how their periods might change towards the end of their reproductive life, finds a new study led by UCL researchers. The research, published in Post Reproductive Health, highlighted how as women approach the menopause, their periods may become unpredictable, heavy and cause worse premenstrual symptoms – including mood swings, breast tenderness and headaches. The team of researchers from the UCL EGA Institute of Women’s Health and Centre for Reproductive Health, University of Edinburgh, ...
Why emotions stirred by music create such powerful memories
Key takeaways UCLA psychologists used music to manipulate emotions of volunteers and found the dynamics of their emotions molded otherwise neutral experiences into memorable events. The tug of war between integrating memories and separating them helps to form distinct memories, allowing people to understand and find meaning in their experiences, and retain information. These findings could hold therapeutic promise in helping people with PTSD and depression. Time flows in a continuous stream — yet our ...
Low-quality studies on early interventions for autism dominate the field, says researchers
CHAPEL HILL, N.C. – The Centers for Disease Control and Prevention report that autism is becoming more common in young children. In an effort to improve the challenges young autistic children face as part of their early development, researchers have focused on developing and evaluating nonpharmaceutical interventions that can be provided in early childhood. Micheal Sandbank, PhD, an assistant professor in the Department of Health Sciences at the UNC School of Medicine, is an expert on the research supporting these early interventions, which informs clinical practice across the United States. A new comprehensive meta-analysis, led by Sandbank, shows that many low-quality ...
Study finds possible early predictor of successful transcranial magnetic stimulation therapy for major depression
A new study from UCLA Health researchers demonstrates that a novel treatment is effective in most patients with major depressive symptoms even after multiple failed courses of antidepressant medication. The treatment, repetitive transcranial magnetic stimulation (rTMS), may work even more rapidly than past findings have suggested, starting to alleviate symptoms as quickly as one week. Researchers from the Neuromodulation Division of UCLA’s Semel Institute analyzed the outcomes of hundreds of patients treated at UCLA Health from 2009 to 2022 with rTMS therapy, which uses magnetic fields to effectively “rewire” ...