Aims The efficacy and safety of cardiac rehabilitation for patients with persistent atrial fibrillation who restored sinus rhythm after catheter ablation remains unclear. The aim of the present study was to evaluate the effects of cardiac rehabilitation on exercise capacity, inflammatory status, cardiac function, and safety in patients with persistent atrial fibrillation who had catheter ablation. Methods In this randomized controlled study, 61 patients treated with catheter ablation for persistent atrial fibrillation (male, 80%; mean age, 66 ± 9 years) were analyzed. Thirty patients underwent cardiac rehabilitation (rehabilitation group), whereas the remaining 31 patients received usual care (usual care group). The rehabilitation group underwent endurance and resistance training with moderate intensity, at least three times per week for six months. Six-minute walk distance, muscle strength, serum high-sensitivity C-reactive protein, plasma pentraxin 3, left ventricular ejection fraction and atrial fibrillation recurrence were assessed at baseline and at six-month follow-up. Results In the rehabilitation group, significant increases in the six-minute walk distance, handgrip strength, leg strength and left ventricular ejection fraction and significant decreases in high-sensitivity C-reactive protein and plasma pentraxin 3 concentrations were observed at six-month follow-up compared with baseline (all p < 0.05). No significant changes were observed in the usual care group. During the six-month follow-up period, the number of patients with atrial fibrillation recurrence was six (21.4%) in the rehabilitation group and eight (25.8%) in the usual care group (risk ratio, 0.83; 95% confidence interval, 0.33 to 2.10). Conclusions Cardiac rehabilitation improved exercise capacity without increasing the risk for atrial fibrillation recurrence. It may also be effective in managing systemic inflammatory status and systolic left ventricular function in patients with persistent atrial fibrillation treated with catheter ablation.
Background
Protection from lethal ventricular arrhythmias leading to sudden cardiac death (SCD) is a crucial challenge after acute myocardial infarction (AMI). Cardiac sympathetic and parasympathetic activity can be noninvasively assessed using heart rate variability (HRV) and heart rate turbulence (HRT). The EMBODY trial was designed to determine whether the Sodium–glucose cotransporter 2 (SGLT2) inhibitor improves cardiac nerve activity.
Methods
This prospective, multicenter, randomized, double-blind, placebo-controlled trial included patients with AMI and type 2 diabetes mellitus (T2DM) in Japan; 105 patients were randomized (1:1) to receive once-daily 10-mg empagliflozin or placebo. The primary endpoints were changes in HRV, e.g., the standard deviation of all 5-min mean normal RR intervals (SDANN) and the low-frequency–to–high-frequency (LF/HF) ratio from baseline to 24 weeks. Secondary endpoints were changes in other sudden cardiac death (SCD) surrogate markers such as HRT.
Results
Overall, 96 patients were included (46, empagliflozin group; 50, placebo group). The changes in SDANN were + 11.6 and + 9.1 ms in the empagliflozin (P = 0.02) and placebo groups (P = 0.06), respectively. Change in LF/HF ratio was – 0.57 and – 0.17 in the empagliflozin (P = 0.01) and placebo groups (P = 0.43), respectively. Significant improvement was noted in HRT only in the empagliflozin group (P = 0.01). Whereas intergroup comparison on HRV and HRT showed no significant difference between the empagliflozin and placebo groups. Compared with the placebo group, the empagliflozin group showed significant decreases in body weight, systolic blood pressure, and uric acid. In the empagliflozin group, no adverse events were observed.
Conclusions
This is the first randomized clinical data to evaluate the effect of empagliflozin on cardiac sympathetic and parasympathetic activity in patients with T2DM and AMI. Early SGLT2 inhibitor administration in AMI patients with T2DM might be effective in improving cardiac nerve activity without any adverse events.
Trial Registration: The EMBODY trial was registered by the UMIN in November 2017 (ID: 000030158). UMIN000030158; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034442.
Four weeks of stretching exercises improved vascular endothelial dysfunction through attenuation of oxidative stress in sedentary patients with CHF with an ICD or CRT-D.
IntroductionProtection from lethal ventricular arrhythmias leading to sudden cardiac death is one of the most important problems after myocardial infarction. Cardiac sympathetic hyperactivity is related to poor prognosis and fatal arrhythmias and can be non-invasively assessed with heart rate variability, heart rate turbulence, T-wave alternans, late potentials, and 123I-meta-iodobenzylguanide (123I-MIBG) scintigraphy. Sodium glucose cotransporter 2 (SGLT2) inhibitors potentially reduce sympathetic nervous system activity that is augmented in part due to the stimulatory effect of hyperglycemia. The EMBODY trial is designed to determine whether the suppression of cardiac sympathetic activity induced by the SGLT2 inhibitor is accompanied by protection against adverse cardiovascular outcomes.MethodsThe EMBODY trial is a prospective, multicenter, randomized, double-blind, placebo-controlled trial in patients with acute MI and type 2 diabetes in Japan. A total of 98 patients will be randomized (1:1) to receive once-daily placebo or empagliflozin, an SGLT2 inhibitor, 10 mg. The primary end point is the change from baseline to 24 weeks in heart rate variability. Secondary end points include the change from baseline for other sudden cardiac death surrogate-markers such as heart rate turbulence, T-wave alternans, late potentials, and 123I-MIBG scintigraphy imaging. Adverse effects will be evaluated throughout the trial period.Planned OutcomesThe EMBODY trial will evaluate the potential cardioprotective effect of empagliflozin and will provide additional important new data regarding its preventative effects on sudden cardiac death.Trial RegistrationUnique Trial Number, UMIN000030158 (https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000034442).FundingNippon Boehringer Ingelheim and Eli Lilly and Company.
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