Cross-exclusion of patients with chronic obstructive pulmonary disease and heart failure in randomized controlled drug trials.

Chronic obstructive pulmonary disease (COPD) and heart failure (HF) frequently coexist, yet patients with both conditions are often excluded from randomized controlled trials(RCTs). We conducted a secondary analysis of 72 RCTs (28 COPD/COPD exacerbations (ECOPD); 44 HF) including 181,325 participants. In COPD/ECOPD trials, only 10.8% of participants with HF, while 6.9% explicitly excluded them. In HF trials, 31.4% included participants with COPD, whereas 47.2% excluded them. There is frequent cross-exclusion of patients with coexisting COPD and HF in RCTs, limiting the applicability of current evidence to this clinically significant population with both conditions, and underscoring the need for more inclusive trial designs.