Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure: Baseline characteristics of patients in the RESHAPE-HF2 trial and comparison to COAPT and MITRA-FR trials.

Aim: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials.

Methods And Results: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended.

Supervised exercise training in patients with advanced heart failure and left ventricular assist device: A multicentre randomized controlled trial (Ex-VAD trial).

Aims: Small studies and observations suggested that exercise training may improve peak oxygen consumption (peakVO ) in patients with advanced heart failure and left ventricular assist device (LVAD). We investigated whether in this patient group a supervised exercise training can improve exercise capacity.

Methods And Results: In this multicentre, prospective, randomized, controlled trial, patients with stable heart failure and LVAD were randomly assigned (2:1) to 12 weeks of supervised exercise training or usual care, with 12 weeks of follow-up.

Initial therapeutic anticoagulation with rivaroxaban compared to prophylactic therapy with heparins in moderate to severe COVID-19: results of the COVID-PREVENT randomized controlled trial.

Background: COVID-19 is associated with a prothrombotic state. Current guidelines recommend prophylactic anticoagulation upon hospitalization.

Methods: COVID-PREVENT, an open-label, multicenter, randomized, clinical trial enrolled patients (≥ 18 years) with moderate to severe COVID-19 and age-adjusted D-dimers > 1.

Magnetic resonance imaging of organ iron before and after correction of iron deficiency in patients with heart failure.

Aims: Intravenous iron therapy (IVIT) is known to improve functional status in chronic heart failure (CHF) patients. The exact mechanism is not completely understood. We correlated magnetic resonance imaging (MRI) patterns of T2* iron signal in various organs to systemic iron and exercise capacity (EC) in CHF before and after IVIT.

Effect of face masks on salivary parameters and halitosis: Randomized controlled crossover trial.

Background: Face masking is associated with self-perceived dry mouth and halitosis. Aim of the study was to measure the effect of different face masks on salivary parameters and halitosis.

Methods: The randomized controlled crossover clinical trial with four periods included 40 oral healthy participants using different face masks (cloth mask, surgical mask, filtering facepiece 2 [FFP2] mask) or no mask (control) for 4 h in random order.

Blinded sample size recalculation in adaptive enrichment designs.

In the precision medicine era, (prespecified) subgroup analyses are an integral part of clinical trials. Incorporating multiple populations and hypotheses in the design and analysis plan, adaptive designs promise flexibility and efficiency in such trials. Adaptations include (unblinded) interim analyses (IAs) or blinded sample size reviews.

A conditional error function approach for adaptive enrichment designs with continuous endpoints.

Adaptive enrichment designs offer an efficient and flexible way to demonstrate the efficacy of a treatment in a clinically defined full population or in, eg, biomarker-defined subpopulations while controlling the family-wise Type I error rate in the strong sense. Frequently used testing strategies in designs with two or more stages include the combination test and the conditional error function approach. Here, we focus on the latter and present some extensions.

Clinical trials with nested subgroups: Analysis, sample size determination and internal pilot studies.

The importance of subgroup analyses has been increasing due to a growing interest in personalized medicine and targeted therapies. Considering designs with multiple nested subgroups and a continuous endpoint, we develop methods for the analysis and sample size determination. First, we consider the joint distribution of standardized test statistics that correspond to each (sub)population.

Incidental findings in cardiac magnetic resonance imaging: superiority of bSSFP over T1w-HASTE for extra-cardiac findings assessment.

Incidental findings are frequent in radiological examinations and may have an impact on further patient management. The aim of this retrospective study was to analyze, which of two thoracic scout sequences is more suitable for detecting incidental extra-cardiac findings at cardiac magnetic resonance imaging (CMRI) with stress perfusion. During a 14-month period clinically indicated stress perfusion CMRI was performed in 97 consecutive patients.

NGAL expression during cardiopulmonary bypass does not predict severity of postoperative acute kidney injury.

Background: Renal injury is a serious complication after cardiac surgery and therefore, early detection and much more prediction of postoperative kidney injury is desirable. Neutrophil gelatinase-associated lipocalin (NGAL) is a predictive biomarker of acute kidney injury and may increase after cardiopulmonary bypass (CPB). However, time correlation of NGAL expression and severity of renal injury is still unclear.

Estimation of Box's ε for low- and high-dimensional repeated measures designs with unequal covariance matrices.

We present new inference methods for the analysis of low- and high-dimensional repeated measures data from two-sample designs that may be unbalanced, the number of repeated measures per subject may be larger than the number of subjects, covariance matrices are not assumed to be spherical, and they can differ between the two samples. In comparison, we demonstrate how crucial it is for the popular Huynh-Feldt (HF) method to make the restrictive and often unrealistic or unjustifiable assumption of equal covariance matrices. The new method is shown to maintain desired α-levels better than the well-known HF correction, as demonstrated in several simulation studies.