Latest news with #atrialfibrillation
Medscape
10 hours ago
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- Medscape
Two UK Cardiology Trials Struggle to Recruit Patients
MANCHESTER — Two ongoing cardiology trials in the UK are facing substantial recruitment challenges, researchers reported at the British Cardiovascular Society (BCS) Annual Conference 2025. The BRITISH study has enrolled fewer than one-third of its targeted 2504 patients over 2 years. Meanwhile, CRAAFT-HF has recruited just 22 of its 1200-patient goal since launching in December 2024. 'We are running behind schedule,' said Andrew Flett, a consultant cardiologist at University Hospital Southampton NHS Trust and principal investigator for BRITISH. 'We're running at about 50% of where we should be, and we're putting in every effort to try and improve that.' CRAAFT-HF's chief investigator Pier Lambiase, professor of cardiology at University College London, said that the trial's eligibility criteria were 'evolving' and being adjusted to boost recruitment. Entry Criteria Adjustments for CRAAFT-HF CRAAFT-HF is comparing surgical versus medical ablation of atrial fibrillation (AF) in people with heart failure and a reduced ejection fraction (EF) of 50%. The trial is still in its vanguard phase, with 14 centres open for an average of 4.5 months. The aim was to have at least 120-215 patients recruited across 10 sites within the first year. Professor Pier Lambiase Despite a large potential pool of patients with heart failure and AF seen in clinics, 'only about 5% are referred for ablation', Lambiase said. To improve recruitment, proposed changes include: Broadening the definition of AF to include paroxysmal and persistent types (up to 3 years' duration), confirmed by ECG, Holter monitoring, or cardiac implantable electronic devices (CIEDs). Relaxing inclusion thresholds for New York Heart Association (NYHA) class and LVEF thresholds. Removing NT-proBNP and medication optimisation criteria for trial eligibility. 'We've learned very quickly that this is threatening the trial,' Lambiase said. 'It's a lot of work to get the patient recruited, start optimal therapy, repeat the [echocardiogram], make sure they're still in the trial.' He estimated the revised criteria could have added 62 patients – tripling current enrolment. Lambiase remains optimistic, citing remote follow-up protocols and international collaboration plans with centres in Canada, Australia, Sweden, and Spain. Expanding the pool of associate principal investigators to include nurses and pharmacists may also help accelerate recruitment. The BRITISH Study The BRITISH study, active since 2023, is running at 46 of its planned 50 UK sites and actively recruiting. Ongoing since 2023, 46 out of the planned 50 sites are actively recruiting patients into the BRITISH study. It aims to determine whether scarring detected via cardiovascular magnetic resonance (CMR) is associated with reduced mortality in patients with nonischaemic cardiomyopathy and severe systolic heart failure (LVEF ≤35%) who receive implantable cardioverter defibrillators (ICDs). Andrew Flett Flett reported that of the 390 patients enrolled so far: Half were recruited within one year of diagnosis. Just under 20% were recruited within 6 months. Almost two-thirds had NYHA Class II heart failure. 38% had AF. Flett said this is 'the best-treated heart failure population in a heart failure trial that I'm aware of', noting high rates of evidence-based therapy: 93% on beta-blockers. 97% on antihypertensives. 92% on sodium-glucose cotransport 2 (SGLT2) inhibitors. 88% on mineralocorticoid receptor antagonists. The median age is 66 years. Most participants are White (93%) and male (80%). Addressing Gender Disparities in Trial Recruitment The under-representation of women — just 20% of the current cohort — is 'a major source of concern', Flett told Medscape News UK . The BCS and the British Heart Foundation Clinical Research Collaborative have previously highlighted the need to include more women in clinical trials. A consensus paper in the journal Heart , published at the start of the BCS annual conference, outlined strategies to improve female participation. However, Flett noted that nonischaemic cardiomyopathy is more common in men. 'We're going to recruit the patients that are there, and most of them are men,' he said. If we had 'the luxury of plenty of patients, we could obviously hold back on male recruitment', he added. Efforts are also underway to increase the number of female principal investigators (PIs). Currently, just 6 of the 46 site PIs are women. Recruitment could take another 2-3 years at the current pace. Plans are being considered to open additional sites in Australia and to remind UK centres of the importance of balanced gender recruitment. The BRITISH and CRAAFT-HF studies are funded by the British Heart Foundation. Flett and Lambiase had no conflicts of interest to disclose.
Medscape
15 hours ago
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- Medscape
SGLT2 Inhibitors Linked to Lower Risk for AF in T2D
The use of SGLT2 inhibitors was associated with a reduced risk for atrial fibrillation (AF) in patients with type 2 diabetes (T2D). METHODOLOGY: SGLT2 inhibitors have been shown to provide therapeutic benefits to patients with heart failure and AF; however, data on their protective effect on AF in patients without heart failure are inconsistent. Researchers conducted a retrospective case-control study in Germany to assess the association between the use of various antihyperglycemic medications between 2005 and 2023 and the diagnosis of AF in patients with T2D during the same period. They used data from the Disease Analyzer database including 29,424 patients with T2D aged 40 years or older with an initial diagnosis of AF who were matched to an equal number of control patients without AF (mean age at the index date , 76 years; 46%-47% women; average diabetes duration prior to the index date for both cohorts, 6.8 years). Antihyperglycemic therapies included metformin, sulfonylurea, GLP-1 receptor agonists (RAs), DPP-4 inhibitors, SGLT2 inhibitors, and insulin. TAKEAWAY: Treatment with SGLT2 inhibitors was associated with a reduced risk for AF (odds ratio [OR], 0.82; P < .01 per year of therapy). < .01 per year of therapy). GLP-1 RAs were associated with a slightly reduced risk for AF (OR, 0.93; P < .01), with a stronger association among women (OR, 0.89), patients aged 71-80 years (OR, 0.88), and patients older than 80 years (OR, 0.81; P < .01 for all). < .01), with a stronger association among women (OR, 0.89), patients aged 71-80 years (OR, 0.88), and patients older than 80 years (OR, 0.81; < .01 for all). The use of sulfonylurea was linked to a slightly increased risk for AF (OR, 1.09; P < .01), with the strongest association among patients younger than 70 years (OR, 1.18; P < .01). < .01), with the strongest association among patients younger than 70 years (OR, 1.18; < .01). Patients with AF began SGLT2 inhibitor therapy on average 2.6 years before diagnosis, with the therapy lasting an average of 2.3 years. IN PRACTICE: 'SGLT2i [inhibitors] and GLP-1 RA may provide an important, heretofore unknown effect of antidiabetic therapy: The prevention of AF, a cardiac condition of massive prevalence and severe impact for those affected,' the authors wrote. SOURCE: This study was led by Mark Luedde, MD, and Jamschid Sedighi, MD, of the University Hospital of Giessen and Marburg, Giessen, Germany. It was published online on June 03, 2025, in Diabetes, Obesity and Metabolism . LIMITATIONS: This study lacked data on the frequency and duration of AF episodes. The absence of data on cardiovascular disease severity may have affected the balance between groups. Potential bias due to the indication of oral antidiabetic treatments cannot be ruled out. DISCLOSURES: This study did not report any specific funding. The authors reported having no relevant conflicts of interest.
Medscape
23-05-2025
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- Medscape
ECG Challenge: Palpitation Episodes in a COPD Patient
A 70-year-old man presents with a chronic obstructive pulmonary disease (COPD) exacerbation. He reports shortness of breath and palpitations. He has no known heart disease but has experienced palpitations in the past that were short-lived and did not require therapy. Figure 1. Courtesy of Philip J. Podrid, MD. The correct diagnosis is atrial fibrillation with Ashman's phenomenon (Figure 2). Figure 2. Courtesy of Philip J. Podrid, MD. Discussion The rhythm is irregularly irregular, with no organized P waves. The average rate is 174 beats/min. The QRS complex duration (0.08 sec) and morphology are normal. There are only three supraventricular rhythms that are irregularly irregular: Sinus arrhythmia (one P wave morphology and stable PR interval) Multifocal atrial rhythm (also called wandering atrial pacemaker) with a rate < 100 beats/min and multifocal atrial tachycardia with a rate > 100 beats/min (≥ 3 different P wave morphologies and PR intervals without any predominant P wave morphology) Atrial fibrillation in which there are no organized P waves Therefore, this is atrial fibrillation. Noted are several QRS complexes that have an increased duration (0.12 sec) with a right bundle branch block (RBBB) morphology with an RSR' morphology in lead V1 (←) and a broad terminal S wave in lead V5 (→). These complexes are not runs of NSVT, because they have a typical RBBB morphology and their intervals are also irregular. They are not the result of rate-related aberration, because there are other RR intervals as short or even shorter than these aberrated QRS complexes that are not associated with aberration. However, preceding the aberrated complexes is a long (┌┐)-short RR interval (└┘). This is the Ashman's phenomenon which is not caused by an abnormality in His-Purkinje conduction but rather by normal rate-related changes in His-Purkinje refractoriness or time for repolarization. When the heart rate is slow (long RR interval), His-Purkinje refractoriness or time for repolarization prolongs whereas when the heart rate is fast (short RR interval), His-Purkinje refractoriness or time for repolarization shortens. This change in refractoriness or repolarization with heart rate is what causes the QT interval to change with heart rate, ie the QT interval is shorter at a faster heart rate and longer with a slower heart rate. When there is an abrupt change in heart rate from slow (long RR interval) to fast (short RR interval), His-Purkinje refractoriness does not adapt or change immediately and hence one or several QRS complexes are conducted with aberration. Most commonly the aberration is an RBBB, likely because the refractoriness of the right bundle is slightly longer than that of the left bundle.
Medscape
16-05-2025
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- Medscape
GLP-1 Agonists Reduce Recurrent Atrial Fibrillation
SAN DIEGO — Patients with obesity and diabetes are at a substantially reduced risk of having a recurrence of atrial fibrillation (AF) after ablation if they are taking a glucagon-like peptide 1 (GLP-1) receptor agonist vs another diabetes drug, according to an analysis of matched cohorts with 3 years of follow-up. The study was retrospective, but it included more than 2500 patients taking a GLP-1 or one of the two comparators, reported Varun Sundaram, MD, PhD, section chief, Advanced Heart Failure, Louis Stokes Cleveland Veterans Affairs (VA) Medical Center, Cleveland. After a median of 3.1 years of follow-up, the odds ratio (OR) of the primary composite outcome of time to first AF hospitalization, an AF-related procedure, or all-cause mortality was reduced by 13% (OR, 0.87; P = .03) compared with treatment with a dipeptidyl peptidase 4 (DPP-4) inhibitor or sulfonylurea. Weight Loss Might Not Explain Effect While weight loss on the GLP-1 did occur, Sundaram speculates that it did not fully explain the benefit of the drug, as it was only modestly greater than in the control arms (14.1% vs 10.9%). He instead believes GLP-1s have 'pleiotropic' effects, resulting in a favorable impact on the metabolic abnormalities that provide a substrate for AF recurrence. An antidiabetic drug with a favorable impact on the long-term risk for AF recurrence is an important unmet need, according to Sundaram. While ablation offers high rates of acute AF control, he pointed to the fact that one third of patients have a recurrence within 1 year and that rates continue to rise with longer follow-ups. 'We believe this is likely related to progressive atrial substrate remodeling,' said Sundaram, who said this study supports the ability of GLP-1s to reduce the residual risk for AF recurrence after a primary ablation. In this trial, called TRANSFORM-AF, which was a late-breaking clinical trial presented at Heart Rhythm 2025, patients with type 2 diabetes and a body mass index (BMI) > 30 who were starting a new prescription of a GLP-1, DPP-4 inhibitor, or sulfonylurea were drawn from a pool of more than 70,000 patients in the VA system. After propensity matching on the basis of 31 covariates, 1226 patients starting a GLP-1 were compared with 1284 of those taking either a DPP-4 inhibitor or sulfonylurea. The standardized between-group difference for any one of the covariates was less than 10%. In a secondary analysis that assessed repeating AF events with mortality as a competing risk, the risk reduction of AF recurrence over the course of follow-up was 15% (OR, 0.85), which suggested a trend (95% CI, 0.61-1.03). The TRANSFORM-AF study was limited to patients with AF and diabetes only because this is the population in the VA system taking a GLP-1. Sundaram said it is unknown if a similar reduction in recurrence would be observed in patients without diabetes with or without obesity taking a GLP-1. The major limitation of this study was that it was not randomized, Sundaram acknowledged. Despite propensity matching, he cautioned that the risk for residual confounding cannot be excluded. Randomized Trial Needed A randomized trial is needed to confirm these findings, but Sundaram said such a trial will be 'challenging' for a number of reasons. In patients with obesity and diabetes, a study design that includes randomizing patients to drugs other than GLP-1 might impair recruitment. The long-term follow-up required to accrue sufficient events might also make the study cost unattractive. The association between GLP-1 and a reduced risk for AF recurrence in TRANSFORM-AF supported a hypothesis based on experimental studies. In a 2023 editorial accompanying a published study showing a reduction in AF in an animal model of diabetes, the authors of the editorial cited other effects — such as improvement in left ventricular function that they saw as support for effects beyond weight loss and a basis for conducting clinical trials. The level of interest in the concept modifying the substrate of AF recurrence is 'high,' according to Sanjeev Saksena, MD, an electrophysiologist and a clinical professor of medicine at the Robert Wood Johnson Medical School, Rutgers University, New Brunswick, New Jersey. He said this study is an early step in exploring the hypothesis. Saksena considers supportive evidence from a 'robust pilot' study essential to move toward a pivotal trial. He said that the data from this study, although provocative, are insufficient for projecting benefit. On the basis of this study alone, 'there are several reasons to question the impact on AF,' Saksena said. For one, there was a large proportion of patients with obesity, diabetes, and AF who were excluded from the analysis for various reasons. For another, AF was not measured quantitatively. He also pointed to potential problems with the matching technique to optimize two comparable groups. As the Heart Rhythm Society–invited discussant on this study, Saksena called for a randomized trial to prove the hypothesis. He did not agree that such a controlled trial would be impossible, noting that that GLP-1 drugs such as semaglutide are not the first-line treatment for obesity, AF, or diabetes, and that more evidence of a favorable benefit-risk ratio is needed. He pointed out that TRANSFORM-AF had many strengths. For one, the evidence of even greater benefit in those with the highest baseline BMI was reassuring. He also agreed that that new options for preventing AF recurrence are certainly needed. Saksena said he looks forward to further evidence that the evidence of benefit can be confirmed, providing a new option for clinical practice.
