Clinicians who advise patients on lifestyle changes and provide them with written information may wonder if their words have an impact. But it turns out that patients can be positively influenced by these actions after all.
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This is a key point of the initial results of the recently presented TRIM-AF study (targeting risk interventions and metformin for atrial fibrillation), a study by the Cleveland clinic unveiled during the scientific sessions of the American Heart Association at the end of 2024. not The price better than those who have received standards of care – it nevertheless offers notable implications for the treatment of FA.
The researchers were surprised that the norm of care, which included a simple education advice on a healthy food and the exercise, made a difference in the reduction of the FA burden. “One thing we have learned is that our patients can really listen to us and that simple change in lifestyle due to advice or information documents could produce advantages,” explains the main researcher Mina Chung, MDAn electrophysiologist at the Cleveland Clinic.
The study also highlights the importance of randomized trials to assess promising interventions for FA, she adds.
Trim-AF in short, and the justification of metformin
Genomic studies have suggested that metabolic stress can play a role in FA, which has led researchers to focus on medical and lifestyle strategies that act on AMP Kinase, a regulator of metabolic stress, as a potential treatment strategy. In addition, previous retrospective and observational studies of people taking Metformin – which targets metabolic stress routes – for diabetes, suggested that it could offer FA advantages.
Trim-AF was a monocentric study (Cleveland Clinic) company to assess the potential advantages of metformin in this context in a more formal way, using a prospective randomized and open design. The researchers randomly assigned 149 adults with FA and an implantable cardiovascular (ICC) electronic device to one of the four treatment groups:
- Care standard (SOC), made up of written educational materials on nutrition and cardiac health exercise
- Metformin only
- A program to modify the lifestyle / risk factor (which included regular nutrition advice and an exercise prescription targeting weight loss, diet, increase in physical activity / exercise and other risk factors, which may include alcohol consumption, smoking and sleep apnea)
- A combination of modification of lifestyle / risk factors and metformin
Because all the participants had a CIED, the researchers were able to record their daily charge of FA, which was the main criterion for studying the study.
After a year, the researchers found that the FA burden improved in all groups and that the modification of the lifestyle and the metformin did not offer any significant advantage over the burden on the SOC. In fact, improving the FA load compared to the basic line was a little larger in the SOC arm alone than in the arms which included treatment with metformin.
Initial information on advice, lifestyle and the importance of ecr
Dr. Chung and his coïstigators were initially surprised that the SOC group did so well, although it notes that all the groups received discussions on the modification of the lifestyle / risk factor during recruitment and this was then supplemented by written documents in the SOC group. “Even without follow-up advice, this simple intervention can make a difference,” she says.
In addition, at least a third of patients who took metformin stopped the medication due to side effects. “Even if there are retrospective data suggesting that there may be advantages, we cannot recommend to the use of metformin as primary treatment for atrial fibrillation,” said Dr. Chung.
The lowest load of FA at the end of the study was in the group assigned to the modification of the lifestyle / risk factor. Although the Charge of the FA burden in this group was not statistically higher than in other groups, patients who have received a modification of the lifestyle / risk factor (with or without simultaneous Metformane) have had significantly greater improvements in self -deplary AF symptom scores compared to SOC and Metformin groups. “People seem to feel better after having changed diet and exercise,” said Dr. Chung, adding that participants in the modification of the lifestyle / risk factor have lost a modest amount of weight although they do not reach the weight loss goals.
In addition to the above clinical dishes, Trim-Aa highlights the importance of conducting randomized controlled trials for therapies that may seem promising, says Dr. Chung.
She notes that previous research in heart failure and hypertensive has also suggested that statins and ECA inhibitors could offer secondary advantages for FA. “But when they were tested in a randomized trial for FA, no difference was detected,” she observes. “The same seems to happen with metformin.”
“Despite the fact of not suggesting an advantage of metformin in the prevention of FA, it highlights the importance of carrying out randomized trials to test therapy,” adds the electrophysiologist of the Cleveland Clinic Robert Koeth, MD, PHDwho was not involved in the study. “An interesting conclusion is that all study groups have lost weight, and this has been associated with a decrease in the FA load.
Two -year data due soon, as well as additional data sets
Dr. Chung notes that Trim-Aa is a two-year study and that she and her co-vests continue to follow her patients and will soon report two years. “We do not know if none of these interventions, including metformin, could actually start to launch and work better with a longer term continuation,” she said.
The test was confronted with challenges because it was affected by the COVVI-19 pandemic, which led to fewer registered patients and certain lifestyle modification sessions are moved to distant contexts, she notes.
In addition to continuing with the TRIM-AF study, the team has planned several follow-up studies.
“We have collected stool samples for microbiome studies,” said Dr. Chung. “We also have blood samples to examine various” -Mic “biomarkers and analyzes to compare those who responded and those who did not do so. The data we have collected is quite unique and promise interesting ideas in the daily FA load, long -term longitudinal changes and what is happening after interventions such as cardioversion and ablation. “