Trial to improve management of common heart rhythm disorder enrolls first patient
The first EU-wide trial aiming to improve the care of elderly atrial fibrillation patients with additional chronic health conditions has enrolled its first patient. The EHRA-PATHS study is coordinated by the European Society of Cardiology (ESC) and the European Heart Rhythm Association (EHRA) of the ESC.
Atrial fibrillation is the most common heart rhythm disorder, affecting more than 40 million individuals worldwide. The likelihood of developing the condition increases with age and the number of other conditions such as high blood pressure, diabetes, heart failure, coronary artery disease, kidney disease, obesity, and obstructive sleep apnea. Patients with atrial fibrillation have an average of five co-existing conditions, and these comorbidities negatively impact survival. In addition, three-quarters of atrial fibrillation patients take at least five medications.
The EHRA-PATHS trial is evaluating how comorbidities in elderly patients with atrial fibrillation are currently managed. It will then examine whether newly developed care pathways lead to better identification and management of comorbidities compared to the standard of care.
Principal investigator Professor Isabelle Van Gelder said, "Health care systems focus on one disease at a time. This increases the risks of underdiagnosing other conditions and of adverse interactions between medications for different diseases—a scenario which is detrimental to patients and costly for health services.
"EHRA-PATHS will test out new care pathways that provide holistic management for elderly patients with atrial fibrillation by also addressing their other chronic conditions. The trial will be conducted in 14 countries, providing the opportunity to address differences in health care systems throughout Europe."
EHRA-PATHS investigators have developed novel care pathways for 22 common comorbidities and risk factors experienced by patients with atrial fibrillation, of which 12 will be evaluated in this trial: hypertension, hyperlipidaemia, heart failure, overweight/obesity, renal insufficiency, smoking, diabetes, coronary heart disease, valvular disease, physical activity, chronic obstructive pulmonary disease/asthma, and alcohol consumption.
Each care pathway will assist health care professionals to check for or exclude whether a given comorbidity or risk factor is present, in order to guide its further evaluation and effective management. All 12 care pathways have been incorporated into a software tool to enable health care personnel to evaluate atrial fibrillation patients in a systematic and comprehensive way.
The clinical trial is set to recruit patients aged 65 years and older with newly diagnosed atrial fibrillation from 68 hospitals in Austria, Belgium, Bulgaria, Croatia, France, Germany, Greece, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the United Kingdom.
Part one of the study will examine the current management (assessment and treatment) of risk factors and comorbidities in approximately 1,300 patients to establish a baseline picture. Part two will be a randomized controlled trial in 1,080 patients to assess whether the implementation of novel systematic care pathways using a dedicated software tool improves the management of comorbidities associated with atrial fibrillation compared with the standard of care.
The primary endpoint is the number of risk factors and comorbidities that are identified and for which treatment is initiated during baseline mapping (part one) and at the end of the randomized controlled trial (part two). The secondary endpoints include atrial fibrillation symptom burden; ablation; hospitalizations for stroke, heart failure, and severe bleeding; mortality; quality of life; patient and health care professional satisfaction; referrals to other disciplines; and cost-effectiveness.
Principal investigator Professor Michiel Rienstra said, "We hope the trial will show that by using a systematic approach with an easy-to-use software tool, more comorbidities will be identified and treated in patients with atrial fibrillation compared to usual practice.
In addition, we expect that better comorbidity management will consequently improve symptoms and quality of life, while reducing health care costs. Data from the trial will be used to pursue regulatory approval of the software so that it can be made available to health care professionals around Europe."
More information:
Comorbidity management in patients presenting with atrial fibrillation – the EHRA-PATHS Project
Provided by European Society of Cardiology