Key result
COMGERCARDIO framework incorporates geriatric assessment and adaptive designs to improve clinical trials in older adults.
Why the study?
Much contemporary cardiovascular evidence derives from randomized trials designed around biologically homogeneous participants, limiting applicability to older adults living with multimorbidity.
Highlights the need for pragmatic cardiovascular trial designs that incorporate multidimensional geriatric complexity to generate clinically usable evidence for aging populations.
May improve applicability of cardiovascular trials in older adults with multimorbidity; leaves open prospective validation of the COMGERCARDIO framework.
Population aging has shifted the burden of cardiovascular disease toward older adults living with multimorbidity, frailty, cognitive vulnerability, functional impairment, and treatment burden. Yet much of the contemporary cardiovascular evidence still derives from randomized clinical trials (RCTs) designed around biologically homogeneous participants, limiting applicability to real-world geriatric cardiology. Our objective was to perform a comparative methodological analysis of two contemporary European cardiovascular RCTs, HI-COR-65 and SENEKA, as illustrative cases and to propose a geriatric-oriented framework for improving trial design in older adults with cardiovascular multimorbidity. We qualitatively compared both trials across five domains: population representativeness, clinical objectives and outcome hierarchy, exclusion criteria, multidisciplinarity, and patient perspective, including participation burden and patient-reported outcomes. Both trials represent important progress by explicitly enrolling older adults with clinically relevant cardiovascular multimorbidity. However, the analysis identified recurring limitations: geriatric complexity is acknowledged but not operationalized through comprehensive geriatric assessment or vulnerability-based stratification; safety and participation requirements may preferentially select robust older adults; outcome hierarchies remain variably aligned with patient priorities; and intervention models are predominantly pharmacological and monodisciplinary. Future cardiovascular trials in older adults should move from chronological inclusion toward pragmatic, complexity-sensitive design. We propose the Comprehensive Geriatric Cardiology (COMGERCARDIO) framework, which integrates baseline geriatric assessment, vulnerability-adaptive interventions, hierarchical patient-centered outcomes, stratified analysis, and implementation evaluation to generate evidence that is scientifically robust, clinically usable, and equitable for aging populations.
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Bonanad et al. (2026) conducted a review in Cardiovascular multimorbidity. COMGERCARDIO framework (pragmatic trial design) vs. Conventional explanatory trial design was evaluated. The COMGERCARDIO framework proposes integrating baseline geriatric assessment, vulnerability-adaptive interventions, and patient-centered outcomes to improve trial applicability in older adults.
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