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. 2020 Jun;22(6):1032-1042.
doi: 10.1002/ejhf.1818. Epub 2020 Apr 15.

Trends in prevalence of comorbidities in heart failure clinical trials

Muhammad Shahzeb Khan  1 , Ayman Samman Tahhan  2 , Muthiah Vaduganathan  3 , Stephen J Greene  4 , Alaaeddin Alrohaibani  1 , Stefan D Anker  5 , Orly Vardeny  6 , Gregg C Fonarow  7 , Javed Butler  8
Affiliations

Trends in prevalence of comorbidities in heart failure clinical trials

Muhammad Shahzeb Khan et al. Eur J Heart Fail. 2020 Jun.

Abstract

Aims: The primary objective of this systematic review was to estimate the prevalence and temporal changes in chronic comorbid conditions reported in heart failure (HF) clinical trials.

Methods and results: We searched MEDLINE for HF trials enrolling more than 400 patients published between 2001 and 2016.Trials were divided into HF with reduced ejection fraction (HFrEF), HF with preserved ejection fraction (HFpEF), or trials enrolling regardless of ejection fraction. The prevalence of baseline chronic comorbid conditions was categorized according to the algorithm proposed by the Chronic Conditions Data Warehouse, which is used to analyse Medicare data. To test for a trend in the prevalence of comorbid conditions, linear regression models were used to evaluate temporal trends in prevalence of comorbidities. Overall, 118 clinical trials enrolling a cumulative total of 215 508 patients were included. Across all comorbidities examined, data were reported in a mean of 35% of trials, without significant improvement during the study period. Reporting of comorbidities was more common in HFrEF trials (51%) compared with HFpEF trials (27%). Among trials reporting data, hypertension (63%), ischaemic heart disease (44%), hyperlipidaemia (48%), diabetes (33%), chronic kidney disease (25%) and atrial fibrillation (25%) were the major comorbidities. The prevalence of comorbidities including hypertension, atrial fibrillation and chronic kidney disease increased over time while the prevalence of smoking decreased in HFrEF trials.

Conclusion: Many HF trials do not report baseline comorbidities. A more rigorous, systematic, and standardized framework needs to be adopted for future clinical trials to ensure adequate comorbidity reporting and improve recruitment of multi-morbid HF patients.

Keywords: Clinical trials; Comorbidities; Heart failure; Trends.

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Figures

Figure 1
Figure 1
Trends of key comorbidities across all clinical trials of heart failure. The prevalence of smoking decreased over time while the prevalence of cardio-metabolic comorbidities increased. CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease.
Figure 2
Figure 2
Trends of key comorbidities across clinical trials by heart failure (HF) setting. Prevalence of hypertension and atrial fibrillation was highest in HF with reduced ejection fraction (HFrEF) trials whereas hyperlipidaemia and chronic obstructive pulmonary disease (COPD) were more common in HF with preserved ejection fraction (HFpEF) trials. AHF, acute heart failure; CAD, coronary artery disease; EF, ejection fraction.
Figure 3
Figure 3
Trends of key comorbidities across clinical trials by region. The estimated prevalence of smoking, diabetes mellitus, chronic kidney disease, and chronic obstructive pulmonary disease (COPD) was more common in trials conducted exclusively in North America. CAD, coronary artery disease.
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