Key result
Eligible-and-enrolled patients had significantly more severe left ventricular impairment compared to eligible-but-not-enrolled patients, contrasting with typical lower-risk enrolment bias in other cardiovascular trials.
Why the study?
Little is known about factors that determine enrolment versus non-enrolment in chronic ischaemic heart failure interventional randomized controlled trials.
Do clinical characteristics and medical therapy differ between eligible-and-enrolled and eligible-but-not-enrolled patients in chronic ischaemic heart failure myocardial regeneration trials?
Observational (n=526)
No
Do clinical characteristics and medical therapy differ between eligible-and-enrolled and eligible-but-not-enrolled patients in chronic ischaemic heart failure myocardial regeneration trials?
Patients enrolled in chronic ischemic heart failure myocardial regeneration trials have more severe LV impairment than eligible non-enrolled patients, indicating a higher-risk enrolled population.
Answers are grounded in this paper and cite their sources.
Suggests myocardial regeneration trial results may apply to a higher-risk population.
Introduction: Clinical trial applicability to routine clinical practice is a fundamental consideration. Little is known about factors that determine enrolment (vs. non-enrolment) in chronic ischaemic heart failure (CIHF) interventional randomized controlled trials (iRCT). Aim: To compare clinical characteristics and medical therapy in eligible-and-enrolled (E-E) vs. eligible-but-not-enrolled (E-NE) patients in CIHF myocardial regeneration iRCTs. Material and methods: Clinical characteristics and medical treatment were compared for E-E and E-NE in 4 periods (32 months): P1 (iRCT#1 recruitment), P2 (between iRCT#1 and iRCT#2), P3 (iRCT#2 recruitment), P4 (post iRCT#2). iRCT#1 and iRCT#2 shared inclusion/exclusion criteria. Conclusions: CIHF medical management was similar in E-E and E-NE. Ineligibility resulted mainly from recent/planned intervention outside iRCT and age > 80 years. LV impairment was more severe in E-E patients, consistent with higher-risk patient enrolment in CIHF-iRCTs. This contrasts with typical lower-risk patient enrolment in other cardiovascular RCT types and populations.
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Czyż et al. (2022) conducted an observational in Chronic ischaemic heart failure (n=526). Enrolment in myocardial regeneration trials vs. Eligible but not enrolled status was evaluated on Median left ventricular end diastolic volume (EDV) in ml (p=< 0.0001). Eligible-and-enrolled patients had significantly more severe left ventricular impairment compared to eligible-but-not-enrolled patients, contrasting with typical lower-risk enrolment bias in other cardiovascular trials.
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