Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorcio Centro de Investigación Biomédica en Red (CIBER)

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Esmolol Injection [Brevibloc]

    Drug

    Brevibloc® 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

1,000 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Left Ventricle (LV) ejection fraction

Estimated with 3D echocardiography (Both: convectional and with esmolol administration)

Time frame
At Baseline (Day 1) until Month-24 according to cohort
2

Peak measurement of global LV systolic longitudinal strain

Estimated with 3D echocardiography (Both: convectional and with esmolol administration)

Time frame
At Baseline (Day 1) until Month-24 according to cohort
3

Ejection Intraventricular Pressure Difference (EIVPD) measure

Estimated with M-mode echocardiography (Both: convectional and with esmolol administration)

Time frame
At Baseline (Day 1) until Month-24 according to cohort

Secondary outcomes

1

Ejection fraction

Obtained with 2D echocardiography (Simpson's biplane method)

Time frame
At Baseline (Day 1) until Month-24 according to cohort
2

Interleukin (IL)-1β

Biochemical variables in blood in relation to the alteration of the different components of the myocardium

Time frame
At Baseline (Day 1) until Month-24 according to cohort
3

High-sensitivity IL-6 (hsIL-6)

Biochemical variables in blood in relation to the alteration of the different components of the myocardium

Time frame
At Baseline (Day 1) until Month-24 according to cohort
4

Soluble Suppression of Tumorigenicity 2 (ST-2)

Biochemical variables in blood in relation to the alteration of the different components of the myocardium

Time frame
At Baseline (Day 1) until Month-24 according to cohort

Other outcomes

Sponsors and contacts

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