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Comparative analysis of randomized versus real-world populations in heart failure: DIAMOND trial vs CARE-HK registry
Solenn Fabien1, Francesco Fioretti2, Victoria Donachie1
1CSL Vifor, Flughofstrasse 61, Glattbrugg 8152, Switzerland.
Insights
Real-world heart failure patients differ significantly from clinical trial participants. Registries like CARE-HK show greater diversity and comorbidity, highlighting the need for more inclusive trials.
Area of Science:
- Cardiology
- Clinical Research
- Real-World Evidence
Background:
- Patiromer effectively reduced hyperkalemia risk in heart failure (HF) patients during the DIAMOND RCT.
- The generalizability of RCT findings to routine clinical practice for HF patients remains uncertain.
Purpose of the Study:
- To compare the eligibility, clinical characteristics, and treatment patterns of patients in the CARE-HK registry versus the DIAMOND trial.
- To assess the real-world applicability of DIAMOND trial findings in a broader HF population.
Main Methods:
- Comparison of patient demographics, comorbidities, and medication use between the CARE-HK registry and the DIAMOND RCT.
- Analysis of eligibility criteria adherence and clinical profiles in both study populations.
Main Results:
- Only 17.2% of CARE-HK participants met DIAMOND eligibility criteria (3.4% with complete data).
- CARE-HK enrolled an older, more diverse population with a higher comorbidity burden and advanced renal dysfunction.
- Higher use of guideline-directed medical therapy (GDMT) in CARE-HK's HF with reduced ejection fraction (HFrEF) subgroup, but suboptimal dosing persisted.
Conclusions:
- Real-world data from registries like CARE-HK are crucial for understanding HF patient diversity and treatment patterns beyond RCTs.
- Findings emphasize the need for more pragmatic and inclusive clinical trials in heart failure research.
- Despite advances, optimizing GDMT and renin-angiotensin-aldosterone system inhibitor dosing in HF remains a challenge.
Introduction:
The DIAMOND randomized controlled trial (RCT) found patiromer to effectively reduce the risk of hyperkalaemic events among patients with heart failure (HF). However, the extent to which the RCT population reflects routine clinical practice remains unclear. We aimed to compare eligibility, clinical profile, and treatment patterns between patients enrolled in the CARE-HK registry and the DIAMOND trial.
Methods:
DIAMOND (NCT03888066), a Phase 3b RCT completed in 2021, and CARE-HK (NCT04864795), a non-interventional registry completed in 2024, both enrolled patients with chronic HF and either active hyperkalaemia or high risk for hyperkalaemia.
Results:
Only 17.2% of CARE-HK participants met DIAMOND's eligibility criteria, dropping to 3.4% when excluding patients with missing data. Compared with DIAMOND, CARE-HK enrolled an older (71.8 vs 67.2 years), more diverse population with more women (31.5% vs 27.6%) and greater burden of comorbidities. Patients exhibited more advanced renal dysfunction, especially in the HF with reduced ejection fraction (HFrEF) population. Within CARE-HK, the use of angiotensin receptor-neprilysin inhibitors (72.1% vs 17.0%), sodium-glucose transport protein 2 inhibitors (69.0% vs 6.6%), and quadruple therapy (47.4% vs 3.9%) was higher in the HFrEF subgroup than in DIAMOND. Despite some progress in prescribing practices, uptake in guideline-directed medical therapy remained incomplete, especially within HFrEF, and renin-angiotensin-aldosterone system inhibitor dosing was often suboptimal.
Conclusion:
This study underscores the value of real-world evidence in complementing RCTs by offering insights into population diversity, comorbidity burden, and prescription behaviours, and highlights the need for more pragmatic and inclusive trials in HF.
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