Phase
Condition
Liver Disorders
Hepatic Fibrosis
Diabetes And Hypertension
Treatment
Esmolol Injection [Brevibloc]
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years.
Absence of previous heart disease, defined as the absence of relevant cardiacstructural alterations such as moderate or severe hypertrophy, alteration ofsegmental contraction, Moderate or severe valvular disease, intraventricularobstructive gradient, or old myocardial infarction.
Existence of an at least acceptable ultrasonic window, which allows thevisualization of at least 14 of the 17 segments of the LV myocardium.
Sinus rhythm, with a basal heart rate greater than 50 bpm.
Diabetic patients with a diagnosis of Diabetes Mellitus 2 (DM2) with or withoutHeart Failure with Normal Ejection Fraction (HFNEF) (n = 300) will be included.Previous diagnosis of HFNEF with clinical stability at the time of inclusion (n = 200). No previous diagnosis of HFNEF (n = 100).
200 patients with cirrhosis stratified by the following additional criteria will beincluded: Child-Pugh A class (n = 25); Child-Pugh B class (n = 75); Child-Pugh Cclass (with and without ascites n = 50 and n = 50, respectively).
300 cancer patients will be included, divided into 3 therapeutic groups: 125patients diagnosed with Lymphoma or Sarcoma receiving chemotherapy based onanthracyclines at high doses (≥ 240 mg / m2); 125 patients with Human Epidermalgrowth factor Receptor 2 (HER2) positive breast cancer receiving chemotherapyregimen that includes trastuzumab without anthracyclines; 50 patients withhepatocarcinoma receiving treatment with Sorafenib.
Expected survival> 6 months, first-diagnosis of cancer, and receiving treatment withchemotherapy that includes any of the previous schemes.
A control group (n = 200) without heart disease and without any of the studyconditions will be included: diabetes from any cause, cancer or active cancertreatment or some degree of liver disease.
Exclusion
Exclusion Criteria:
Contraindication for the administration of esmolol (according to technical datasheet): Hypersensitivity to esmolol hydrochloride; Severe sinus bradycardia (HR <50bpm); 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 daysbefore the study.
History of ventricular or supraventricular arrhythmias that prevent the safewithdrawal of antiarrhythmic or braking treatment before the administration ofesmolol.
History of previous high-grade atrioventricular (AV) conduction disorder innon-pacemaker patients.
Severe asthma with bronchial hyperresponsiveness.
Patients with acute infection.
Participants in other clinical trials in the 30 days prior to the start of thestudy.
Pregnant women, or who plan to be, and women during breastfeeding.
Patients with limitation to follow the protocol for any reason.
Diagnosis of Diabetes Mellitus (DM) of any type other than type 2 [type 1, LatentAutoimmune Diabetes in Adults (LADA), Maturity-Onset Diabetes of the Young (MODY),New Onset Diabetes After Transplant (NODAT), etc.]
Patients in New York Heart Association (NYHA) functional class IV or with advancedheart failure.
Treatment with an oral beta-blocker at the time of the examination that cannot besafely temporarily suspended 72 hours before the test.
Active evidence of Hepatitis B Virus (HBV) or Hepatitis B Virus (HCV) infection.
Personal history of previous cancer requiring systemic treatment (excludes skin orlocalized cancers treated locally surgically).
Previous exposure to systemic antitumor treatment or radiotherapy on the thoracicregion.
Study Design
Study Description
Connect with a study center
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, 28007
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitari i Politècnic La Fe
Valencia, 46026
SpainSite Not Available
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