Characteristics Of Heart Failure Clinical Trials Registered In Clinicaltrials.gov- A Cross Sectional Analysis

ABSTRACT

Purpose: To perform an analysis of trends and characteristics of heart failure (HF) trials registered in ClinicalTrials.gov (CTG). Design(s) Cross-sectional study Methods: All heart failure clinical trials registered on CTG from September 27, 2007 to March 31, 2022 were identified using Advanced Search feature in ClinicalTrials.gov. Trial characteristics were assessed through relative frequency calculations. Hazard ratio and 95% confidence intervals were determined for characteristics associated with early discontinuation. Result(s) A total of 4272 clinical trials were registered in CTG during this period. There were 68.8% interventional studies and 31.2% were observational studies. Patient registry studies constituted 15.8% of observational studies. Interestingly, registry studies in HF were more frequent compared overall clinical studies (4.8% vs 2.5%). In HF, 32.4% trials were funded by industry, 6.6% trials were by funded the National Institute of Health (NIH) and other U.S Federal agencies (FA) and 61.8% trials by all others which includes individuals, universities, research organizations etc. Observational studies constituted 28% of the industry sponsored trials in HF versus 15% of the total registered clinical trials. Completion rate were 58.9% for NIH and FA funded trials as compared to 50% for industry sponsored and 38.9% for other sponsored. Discontinuation rates were 9.6% for NIH and FA funded trials as compared to 16.8% for industry sponsored. On the other hand unknown status of the trial was higher for other sponsors (19.8%) as compared to NIH and FA (3.2%) and industry sponsors (9.3%). Trend analysis for last 15 years showed an increasing number of clinical trials in HF each year. During the two years of COVID-19 pandemic (April 2020 to March 2022) 15.5% total number of trials registered were in HF even though the number of NIH and FA funded trials decreased by 28.9%. This was much higher than the previous two years (April 2018 to March 2020). Total of 492 trials (11.52%) were withdrawn, suspended or discontinued early. Trials were less likely to be discontinued if funded by sources other than industry and NIH considered together (OR 1.93;X2= 47.50;p<0.01). A detailed analysis of various phases of trials and trends of discontinued trials will also be presented. Conclusion(s) Number of clinical trials in HF are increasing. Registry trials and observational studies are more common in HF. Number of HF trials increased during COVID-19 pandemic. Trials funded by NIH and FA have better completion rate, whereas discontinuation rates were much higher for industry sponsored trials.Copyright © 2022