August 3, 2026 · Circulation · DOI: 10.1161/CIR.0000000000001458

Methodologic Standards for Follow-Up Extension in Cardiovascular Trials: A Scientific Statement From the American Heart Association

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The authors aim to establish methodologic standards for follow-up extension trials in cardiovascular research to enhance understanding of long-term safety and efficacy of interventions. They address the need for consistent design, analysis, and reporting practices, while also discussing practical considerations such as participant retention and resource allocation. This statement serves as a guide for improving the quality and reliability of cardiovascular trial extensions.

Mario Gaudino, Sigrid Sandner, Emilia Bagiella, Joshua A Beckman, Emilie P Belley-Cote, Marcus Flather, Alexander C Gregg, Irbaz Hameed, Stuart Pocock, Björn Redfors, Frank Rockhold, American Heart Association Leadership Committee of the Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Lifelong Congenital Heart Disease and Heart Health in the Young

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