Publications by authors named "Naccarelli G"

Study Objective: There is inadequate awareness of the effect of food on the bioavailability of dronedarone. We report results from two phase 1 studies assessing the effect of food on dronedarone's bioavailability.

Design Setting And Participants: Study 1; single-center, open-label, randomized study in healthy adults (males and females).

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Background: There is conflicting data on the association between pre-orthotopic heart transplant (OHT) amiodarone use and post-OHT graft dysfunction (GD) leading to heterogeneity in clinical practice.

Methods: We performed a meta-analysis to evaluate whether pre-OHT amiodarone use was associated with meaningful increases in the incidence of GD, 30-day mortality, and 1-year mortality. Studies were identified by searching PubMed and the Cochrane Register of Clinical Trials.

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Background: Atrial fibrillation and atrial flutter represent the most prevalent clinically significant cardiac arrhythmias. While the CHA2DS2-VASc score is commonly used to inform anticoagulation therapy decisions for patients with these conditions, its predictive power is limited. Therefore, we sought to improve risk prediction for left atrial appendage thrombus (LAAT), a known risk factor for stroke in these patients.

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Obesity significantly increases the risk of developing atrial fibrillation (AF) and atrial flutter (AFL) and evidence from randomized trials indicates that weight loss may reduce the burden of AF/AFL in obese patients; however, the relationship between obesity and healthcare resource utilization in AF/AFL patients is lacking. We sought to assess this relationship in patients with newly diagnosed AF/AFL in a nationally representative cohort of the United States by using the MarketScan® claims database. International Classification of Diseases, Tenth Revision [ICD 10] diagnosis codes were used to select individuals with a new diagnosis of AF/AFL in 2017 and 2018, adjudicate baseline variables and to classify them according to obesity status.

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Article Synopsis
  • The study aimed to investigate how the presence of multiple health conditions (multimorbidity) affects the response to treatments in clinical trials involving nearly 30,000 participants.
  • By reanalyzing data from 8 trials, researchers classified patients based on the Charlson Comorbidity Index (CCI) and examined its impact on treatment outcomes using statistical models.
  • The findings indicated that most participants had low to moderate CCI scores, but notable treatment effects were observed based on higher comorbidity levels, suggesting a need for further research focused on those with more complex health issues.
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Apparent resistant hypertension, defined as uncontrolled office blood pressure despite ≥ 3 antihypertensive medications including a diuretic or use of ≥ 4 medications regardless of blood pressure, occurs in ≤ 15% of treated hypertensives. Apparent refractory hypertension, defined as uncontrolled office pressure despite use of 5 or more medications including a diuretic, occurs in ≤ 10% of resistant cases. Both are associated with increased comorbidity and enhanced cardiovascular risk.

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Background: Pulmonary vein isolation (PVI) is the primary technique for ablation of atrial fibrillation (AF). It is unclear whether adjunctive therapies in addition to PVI can reduce atrial arrhythmia recurrence (AAR) compared to PVI alone in patients with AF.

Methods: A meta-analysis of randomized controlled trials comparing PVI plus an adjunctive therapy (autonomic modulation, linear ablation, non-pulmonary vein trigger ablation, epicardial PVI [hybrid ablation], or left atrial substrate modification) to PVI alone was conducted.

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Renal denervation is not a cure for hypertension. Although more recent sham-controlled trials were positive, a significant minority of patients in each trial were unresponsive. The optimal patient or patients need to be defined.

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A comprehensive approach to hypertension requires out-of-office determinations by home or ambulatory monitoring. The 4 phenotypes comparing office and out-of-office pressures in treated and untreated patients include normotension, hypertension, white-coat phenomena, and masked phenomena. Components of out-of-office pressure may be equally as important as mean values.

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Aims: This post hoc analysis of the ATHENA trial (NCT00174785) assessed the effect of dronedarone on the estimated burden of atrial fibrillation (AF)/atrial flutter (AFL) progression to presumed permanent AF/AFL, and regression to sinus rhythm (SR), compared with placebo.

Methods And Results: The burden of AF/AFL was estimated by a modified Rosendaal method using available electrocardiograms (ECG). Cumulative incidence of permanent AF/AFL (defined as ≥6 months of AF/AFL until end of study) or permanent SR (defined as ≥6 months of SR until end of study) were calculated using Kaplan-Meier estimates.

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Renal denervation (RD) has been investigated as an invasive blood pressure (BP) lowering treatment for hypertension (HTN). Resistant HTN (RHTN) has been defined as uncontrolled BP despite use of 3 antihypertensive medications of different classes, including a diuretic, at maximum tolerated doses. The impact of RD on RHTN remains under investigation.

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Background: Oral anticoagulation (OAC) reduces the risk of thromboembolic events in patients with atrial fibrillation (AF); however, thromboembolism (TE) still can occur despite OAC. Factors associated with residual risk for stroke, systemic embolism, or transient ischemic attack events despite OAC have not been well described.

Objective: The purpose of this study was to evaluate the residual risk of thromboembolic events in patients with AF despite OAC.

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Treatment strategies that modulate autonomic tone through interventional and device-based therapies have been studied as an adjunct to pharmacological treatment of heart failure with reduced ejection fraction (HFrEF). The main objective of this study was to perform a meta-analysis of randomized controlled trials which evaluated the efficacy of device-based autonomic modulation for treatment of HFrEF. All randomized-controlled trials testing autonomic neuromodulation device therapy in HFrEF were included in this trial-level analysis.

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