About this trial
The purpose of this study is to assess the superiority of esmolol echocardiography over conventional echocardiography in the diagnosis of subclinical myocardial involvement associated with diabetes mellitus 2, cirrhosis and antineoplastic treatments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years.
Absence of previous heart disease, defined as the absence of relevant cardiac structural alterations such as moderate or severe hypertrophy, alteration of segmental contraction, Moderate or severe valvular disease, intraventricular obstructive gradient, or old myocardial infarction.
Existence of an at least acceptable ultrasonic window, which allows the visualization of at least 14 of the 17 segments of the LV myocardium.
Sinus rhythm, with a basal heart rate greater than 50 bpm.
Disqualifiers
Contraindication for the administration of esmolol (according to technical data sheet): Hypersensitivity to esmolol hydrochloride; Severe sinus bradycardia (HR <50 bpm); 2nd or 3rd degree atrioventricular block without pacemaker; Cardiogenic shock, severe hypotension, or decompensated heart failure; Untreated pheochromocytoma; Acute asthmatic attack; Concomitant intravenous administration or within the first 48 hours after verapamil.
Treatment with beta-blocker drugs (oral, topical or intravenous) in the last 7 days before the study.
History of ventricular or supraventricular arrhythmias that prevent the safe withdrawal of antiarrhythmic or braking treatment before the administration of esmolol.
History of previous high-grade atrioventricular (AV) conduction disorder in non-pacemaker patients.
Trial design
Sequential
Treatments tested in this trial
Esmolol Injection [Brevibloc]
DrugBrevibloc® will be administered intravenously by infusion pump following the administration schedule: Loading dose of 500 μg/kg for 1 minute, followed by a maintenance infusion of 50 μg/kg/minute over 5 minutes. If the target response is not obtained, the loading dose is repeated and the 50 dose is increased by 50 μg/kg/minute to a maximum of 200 μg/kg/minute. The objective response to esmolol beta-blockade is defined as a 15-20% reduction in heart rate, with lower limits of 55 bpm and a systolic blood pressure not less than 90 mmHg and diastolic blood pressure not less than 50 mmHg. The perfusion is kept active while the echocardiography image acquisition is completed (approx. 15-30 min).
Treatment groups
Trial outcomes
Primary outcomes
Left Ventricle (LV) ejection fraction
Estimated with 3D echocardiography (Both: convectional and with esmolol administration)
Peak measurement of global LV systolic longitudinal strain
Estimated with 3D echocardiography (Both: convectional and with esmolol administration)
Ejection Intraventricular Pressure Difference (EIVPD) measure
Estimated with M-mode echocardiography (Both: convectional and with esmolol administration)
Secondary outcomes
Ejection fraction
Obtained with 2D echocardiography (Simpson's biplane method)
Interleukin (IL)-1β
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
High-sensitivity IL-6 (hsIL-6)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Soluble Suppression of Tumorigenicity 2 (ST-2)
Biochemical variables in blood in relation to the alteration of the different components of the myocardium
Sponsors and contacts
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Consorcio Centro de Investigación Biomédica en Red (CIBER)
Lead sponsor
Instituto de Salud Carlos III
Collaborator