Academic Journal
Eligible-and-enrolled vs. eligible-but-not-enrolled patients with chronic ischaemic heart failure in randomized clinical trials of myocardial regeneration
| العنوان: | Eligible-and-enrolled vs. eligible-but-not-enrolled patients with chronic ischaemic heart failure in randomized clinical trials of myocardial regeneration |
|---|---|
| المؤلفون: | Czyż, Łukasz, Chmiel, Jakub, Drabik, Leszek, Mazurek, Adam, Kwiecień, Ewa, Sikorska, Martyna, Skubera, Maciej, Zasada, Wojciech, Podolec, Piotr, Musiałek, Piotr |
| سنة النشر: | 2022 |
| المجموعة: | Jagiellonian University Repository |
| مصطلحات موضوعية: | randomized clinical trials, myocardial regeneration, eligibility, enrolment, heart failure, selection bias |
| الوصف: | 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. Results: Evaluation involved 5,436 hospitalized patients (P1-P4; CIHF-526). 283 were iRCT eligible (53.8%). The eligibility rate was similar throughout P1-P4 (43.1–58.5%, p = 0.08). Eligible patient characteristics and pharmacotherapy did not differ in recruitment vs. non-recruitment periods. Principal reasons for ineligibility were recent/planned cardiac intervention outside iRCT (22.8%), age above threshold (14.6%) and coexisting disease as the exclusion criterion (12.2%). Primary reasons for eligible patient non-enrolment (n = 89) were other trial participation (52.8%) and no consent (28.1%). E-E patients did not differ from E-NE in characteristics including CIHF medical management and clinical stage; the exception was more severe left ventricular impairment in E-E (LVEF 31.2 vs. 33.9%, p = 0.039; end-diastolic volume 197.8 vs. 160.4 ml, p < 0.0001). 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| Relation: | https://ruj.uj.edu.pl/xmlui/handle/item/305364 |
| DOI: | 10.5114/aic.2022.121133 |
| الاتاحة: | https://ruj.uj.edu.pl/xmlui/handle/item/305364 https://doi.org/10.5114/aic.2022.121133 https://www.termedia.pl/Eligible-and-enrolled-vs-eligible-but-not-enrolled-patients-with-chronic-ischaemic-heart-failure-in-randomized-clinical-trials-of-myocardial-regeneration,35,48159,0,1.html |
| Rights: | Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne - Na tych samych warunkach 4.0 Międzynarodowa |
| رقم الانضمام: | edsbas.EE9F59F5 |
| قاعدة البيانات: | BASE |
| DOI: | 10.5114/aic.2022.121133 |
|---|