Prospective, multicenter, open-label study to evaluate the efficacy of esmolol in the early identification of cardiovascular disorders induced by cirrhosis, diabetes mellitus, and cardiotoxic treatments (CIBER-bB-ECHO).
- Conditions
- Patients with cardiovascular alterations induced by cirrhosis, diabetes mellitus and cardiotoxic treatments.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
Age = 18 years., Absence of previous heart disease, defined as the absence of relevant cardiac structural alterations such as moderate or severe hypertrophy, altered segmental contraction, moderate or severe valvular heart disease, intraventricular obstructive gradient, or old myocardial infarction., Existence of at least an acceptable ultrasound window, allowing visualization of at least 14 of the 17 segments of the LV myocardium., Sinus rhythm, with basal heart rate above 50 bpm.
Contraindication for the administration of esmolol (according to technical data sheet): a. Hypersensitivity to esmolol hydrochloride. b. Severe sinus bradycardia (HR < 50 bpm). c. 2nd or 3rd degree atrioventricular block without pacemaker. d. Cardiogenic shock, severe hypotension, or decompensated heart failure. e. Untreated pheochromocytoma. f. Acute asthmatic crisis. g. Concomitant intravenous administration or in the first 48 hours after administration of verapamil., Treatment with beta-blocking drugs (oral, topical or intravenous) in the last 7 days before the study., History of ventricular or supraventricular arrhythmias that preclude safe withdrawal of antiarrhythmic or braking therapy prior to esmolol administration., History of previous high-grade AV conduction disorder in patients without pacemakers., Severe asthma with bronchial hyperresponsiveness., Patients with acute infection., Participants in other clinical trials in the 30 days prior to the start of the study., Women who are pregnant, or plan to become pregnant, and women who are breastfeeding., Patients with limitation to follow the protocol for any cause.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method