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

Authors

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

Published in

Circulation. Aug 03, 2026. Epub Aug 03, 2026.

Abstract

Extension follow-up trials are essential for understanding the long-term safety and efficacy of cardiovascular interventions. Whereas primary randomized trials primarily capture short-term outcomes, extended observation may reveal delayed benefits or harms that are highly relevant to clinical decision-making. However, methodologic standards for extension trials remain poorly defined, leading to inconsistent design, analysis, and reporting. This scientific statement outlines best practices for cardiovascular trial extensions, addressing outcome selection, duration and completeness of follow-up, and analytic strategies suited to evolving treatment effects. Practical considerations, including strategies for participant retention, reconsent, data continuity, and resource allocation, are also discussed.

PMID:
42544461
Bibliographic data and abstract were imported from PubMed on 03 Aug 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.