{"id":"7a3353960d55","type":"article","url":"https://hartvaat.nl/2025/12/18/improve-dice-veiligheid-en-werkzaamheid-van-ninerafaxstat-bij-cardiometabole-syn/","title":"IMPROVE-DiCE: veiligheid en werkzaamheid van ninerafaxstat bij cardiometabole syndromen","title_en":"IMPROVE-DiCE, a 2-Part, Open-Label, Phase 2a Trial Evaluating the Safety and Effectiveness of Ninerafaxstat in Patients With Cardiometabolic Syndromes","category":"algemeen","category_label":"Algemeen","professions":["apotheker","cardioloog"],"tags":[],"journal":"Circulation","doi":"https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.125.074041","source_url":"https://doi.org/https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.125.074041","authors":[],"significance":8,"published":"2025-12-18","source_date":"2025-12-18","image":"","kennis":["https://hartvaat.nl/kennis/farmacologie/betablokkers-cardiale-indicaties/"],"congress":"","summary_en":"The IMPROVE-DiCE phase 2a trial evaluated ninerafaxstat, a novel agent designed to improve diabetic cardiac energetics, in patients with diabetic cardiomyopathy. The study explores a new therapeutic mechanism targeting myocardial metabolism.","created":"2026-07-03T10:25:40Z","updated":"2026-07-03T13:25:03Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"IMPROVE-DiCE is een tweedelige open-label fase 2a-trial die de veiligheid en werkzaamheid evalueert van ninerafaxstat, een nieuw middel ontworpen om de cardiale energiehuishouding te verbeteren bij cardiometabole syndromen.","abstract_original":"BACKGROUND:We report IMPROVE-DiCE (Improve Diabetic Cardiac Energetics), a 2-part open-label, phase 2a trial evaluating the safety and effectiveness of ninerafaxstat, a novel therapeutic designed to enhance cardiac energetics. Between May and September 2021, part 1 enrolled patients with type 2 diabetes and obesity without heart failure with preserved ejection fraction (HFpEF). Between January 2023 and June 2024, part 2 enrolled patients with type 2 diabetes, obesity, and HFpEF.METHODS:Forty-two participants received 200 mg ninerafaxstat twice daily (part 1, n=21, 43% women, 72±0.5 years of age, 4–8 weeks; part 2, n=21, 29% women, 71±6 years of age, 12 weeks). Myocardial energetics (phosphocreatine-to-ATP ratio [PCr/ATP], primary outcome) and function (rest and dobutamine stress) were assessed before and after treatment using magnetic resonance imaging,31P- and1H magnetic resonance spectroscopy. In part 1, hyperpolarized [1-13C]pyruvate magnetic resonance spectroscopy to assess in vivo"}