Predictors of discontinuation and non-publication of heart failure clinical trials: A cross-sectional analysis of ClinicalTrials.gov data

Abstract

Heart failure (HF) is a major public health challenge that depends on continuous clinical research to guide care. However, the frequent discontinuation and nonpublication of HF trials may impede scientific progress and limit the impact of research efforts.

Methods

We conducted a cross-sectional analysis using ClinicalTrials.gov to determine all completed, discontinued, or published HF clinical trials (January 2000–June 2022). For each trial, data on the trial phase, funding source, intervention type, enrollment, trial completion, and publication status were extracted. Logistic regression was used to identify predictors of trial completion and publication.

Results

Of the 1181 HF trials identified, 288 (24.3 %) were discontinued. Among the 893 completed trials (75.6 %), 344 (38.5 %) remained unpublished. Trials with ≥100 participants were less likely to be discontinued (OR 0.25; 95 % CI 0.17–0.36; P < 0.01) and more likely to be published (OR 2.10; 95 % CI 1.47–3.03; P < 0.001). Trials exclusively involving females (compared to male-only trials) had a higher likelihood of discontinuation (OR 52.29 [5.07–1332.01], p < 0.01), though no significant association with publication status. Randomized trials (OR 2.16; 95 % CI 1.06–4.43; P = 0.04) and quadruple-blinded trials (OR 0.54; 95 % CI 0.34–0.86; P = 0.01) were more likely to be discontinued; however, if completed, they were less likely to remain unpublished (OR 0.51, 95 % CI 0.29–0.88, p = 0.02; and OR 0.42, 95 % CI 0.26–0.67, p < 0.001, respectively). Behavioral interventions were less likely to be discontinued (OR 0.11, 95 % CI 0.01, 0.55; P = 0.03).

Conclusion

Many HF trials are discontinued or unpublished, limiting the impact of participant contribution. Greater efforts to publish results can help ensure these contributions advance research and reduce bias.