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Rationale and design of the HOVON 170 DLBCL-ANTICIPATE trial: preventing anthracycline-induced cardiac dysfunction with dexrazoxane.
Cardiooncology
January 2025
Department of Hematology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Background: Dexrazoxane has been studied for its ability to prevent anthracycline-induced cardiac dysfunction (AICD) in several trials but its use in clinical practice remains limited. This is related to the low to moderate quality of the generated evidence, safety concerns and restricted prescribing indications. Additional randomized trials are needed before this drug can be routinely integrated into cardio-oncology clinical practice.
View Article and Find Full Text PDFContinuous risk monitoring and management of heart failure: Rationale and design of the ALLEVIATE-HF trial.
Eur J Heart Fail
January 2025
Medical University of South Carolina, Charleston, SC, USA.
Aims: Early identification and management of worsening heart failure (HF) is necessary to prevent disease progression and hospitalizations. The ALLEVIATE-HF (Algorithm Using LINQ Sensors for Evaluation and Treatment of Heart Failure) trial is a prospective, randomized, controlled, double-blind, multicentre trial that aims to assess the safety and efficacy of using the Reveal LINQ™ insertable cardiac monitor (ICM) in patients with HF to continuously monitor and evaluate HF risk status and guide timely interventions.
Methods: The ICM algorithm uses parameters derived from electrocardiogram (atrial fibrillation [AF], ventricular rate during AF, heart rate variability, and night heart rate), three-axis accelerometer (patient activity duration), and subcutaneous bioimpedance (fluid volume, respiration rate).
External beam radiation therapy versus radical prostatectomy for high-risk prostate cancer: protocol of the RECOVER study.
BMC Cancer
January 2025
Netherlands Comprehensive Cancer Organisation, Utrecht, the Netherlands.
Background: This paper describes the rationale and design of the RECOVER study. Currently, there is no consensus regarding the optimal treatment for high-risk, non-metastatic prostate cancer (PCa). The study primarily aims to evaluate and compare the impact of treatment with robot-assisted radical prostatectomy (RP) versus external beam radiation therapy (EBRT) with androgen deprivation therapy (ADT) for men with high-risk, non-metastatic PCa regarding health-related quality of life (HRQoL) and functional outcomes.
View Article and Find Full Text PDFRandomized comparison of the combined Sirolimus eluting and endothelial progenitor cell Combo stent vs. Biolimus eluting absorbable polymer coated BioMatrix Alpha stent in patients undergoing percutaneous coronary intervention. Rationale and study design of the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) XI trial: SORT-OUT XI Trial Design.
Am Heart J
January 2025
Department of Cardiology, Odense University Hospital, Odense, Denmark; University of Southern Denmark, Odense, Denmark.
Rationale: The biodegradable polymer BioMatrix Alpha™ stent contains biolimus A9 drug which is sirolimus derivative increase in lipophicity. The biodegradable polymer sirolimus eluting Combo™ stent is a dual-therapy sirolimus-eluting and CD34+ antobody coated stent capturing endothelial progenitor cells (EPCs).
Hypothesis: The main hypothesis of the SORT OUT XI trial was that the biodegradable polymer biolimus A9 BioMatrix Alpha ™ stent is noninferior to the biodegradable polymer sirolimus eluting Combo™ stent in an all-comers population with coronary artery disease undergoing percutaneous coronary intervention (PCI).
Lerodalcibep and evolocumab for the treatment of homozygous familial hypercholesterolaemia with PCSK9 inhibition (LIBerate-HoFH): a phase 3, randomised, open-label, crossover, non-inferiority trial.
Lancet Diabetes Endocrinol
January 2025
LIB Therapeutics, Cincinnati, OH, USA. Electronic address:
Background: Lerodalcibep, a small binding anti-PCSK9 protein (adnectin), showed effective LDL cholesterol reduction in heterozygous familial hypercholesterolaemia. We aimed to assess the safety and efficacy of lerodalcibep and evolocumab in a globally diverse homozygous familial hypercholesterolaemia population.
Methods: This phase 3, randomised, open-label, crossover, non-inferiority study consisted of two 24-week treatment periods separated by an 8-week washout.
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