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Cardiovascular Outcomes Reported in Hemodialysis Trials
Emma O'Lone1, Andrea K Viecelli2, Jonathan C Craig3
1Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, New South Wales, Australia.
Journal of the American College of Cardiology
|June 16, 2018
Summary
Patients undergoing long-term hemodialysis face high cardiovascular disease risks. Standardized core outcome measures are needed for clinical trials to improve evidence-based decision-making for this population.
Area of Science:
- Nephrology
- Cardiovascular Medicine
- Clinical Trials Methodology
Background:
- Patients on long-term hemodialysis have a significantly elevated risk of cardiovascular disease.
- They are frequently excluded from general and at-risk population clinical trials.
- There is a lack of consensus on universally agreed cardiovascular outcomes for hemodialysis-specific trials.
Purpose of the Study:
- To review the current reporting of cardiovascular outcomes in clinical trials involving hemodialysis patients.
- To highlight the challenges posed by short trial durations, small sample sizes, and heterogeneous outcome measures.
- To emphasize the need for standardized core outcome sets in this high-risk population.
Main Methods:
- Review of existing literature on cardiovascular outcomes in hemodialysis clinical trials.
- Analysis of trial duration, participant numbers, and outcome reporting heterogeneity.
- Discussion of the development of core outcome sets, specifically the Standardized Outcomes in Nephrology-Hemodialysis (SONet-HD) initiative.
Main Results:
- Cardiovascular trials in hemodialysis patients are typically short (median 3-6 months) and small (59% <100 participants).
- Reported cardiovascular outcomes are highly heterogeneous, often using surrogates with uncertain clinical importance.
- Inconsistent outcome reporting hinders meta-analysis and evidence interpretation.
Conclusions:
- Establishing a core outcome measure for cardiovascular disease in hemodialysis is crucial.
- Involving patients, caregivers, and health professionals in defining these outcomes is essential.
- Consistent reporting will strengthen the evidence base for this vulnerable patient group.
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