How to Assess New Treatments for the Management of Heart Failure: Composite Scoring Systems to Assess the Patients’ Clinical Journey

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Key Points

To assess the limitations of mortality-only and surrogate endpoints in heart failure clinical trials and propose a patient-journey composite scoring system.
Reviewed historical trial design paradigms, identifying drawbacks of prioritizing all-cause mortality, isolated surrogate markers, and standard time-to-first-event composite endpoints.
Formulated a composite evaluation framework that systematically integrates serial symptom assessments, changes in background medical therapy, duration of hospitalizations, and mortality.
Identified that conventional mortality trials neglect day-to-day symptomatic burden and require prohibitively large sample sizes, which impedes therapeutic innovation.
Demonstrated that generating a continuous endpoint—such as symptom-adjusted days alive and out of hospital—yields approximately normal data distributions amenable to parametric analysis, substantially increasing statistical power.

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Composite scores may enable efficient small HF trials; leaves open prospective validation before adoption.

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John G.F. Cleland (2002) studied this question.

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