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

Last updated: September 30, 2024
Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disorders

Hepatic Fibrosis

Diabetes And Hypertension

Treatment

Esmolol Injection [Brevibloc]

Clinical Study ID

NCT05769868
ICI20/00011
2021-003889-12
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years.

  2. 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.

  3. Existence of an at least acceptable ultrasonic window, which allows thevisualization of at least 14 of the 17 segments of the LV myocardium.

  4. Sinus rhythm, with a basal heart rate greater than 50 bpm.

  5. 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).

  6. 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).

  7. 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.

  8. Expected survival> 6 months, first-diagnosis of cancer, and receiving treatment withchemotherapy that includes any of the previous schemes.

  9. 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:

  1. 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.

  2. Treatment with beta-blocker drugs (oral, topical or intravenous) in the last 7 daysbefore the study.

  3. History of ventricular or supraventricular arrhythmias that prevent the safewithdrawal of antiarrhythmic or braking treatment before the administration ofesmolol.

  4. History of previous high-grade atrioventricular (AV) conduction disorder innon-pacemaker patients.

  5. Severe asthma with bronchial hyperresponsiveness.

  6. Patients with acute infection.

  7. Participants in other clinical trials in the 30 days prior to the start of thestudy.

  8. Pregnant women, or who plan to be, and women during breastfeeding.

  9. Patients with limitation to follow the protocol for any reason.

  10. 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.]

  11. Patients in New York Heart Association (NYHA) functional class IV or with advancedheart failure.

  12. Treatment with an oral beta-blocker at the time of the examination that cannot besafely temporarily suspended 72 hours before the test.

  13. Active evidence of Hepatitis B Virus (HBV) or Hepatitis B Virus (HCV) infection.

  14. Personal history of previous cancer requiring systemic treatment (excludes skin orlocalized cancers treated locally surgically).

  15. Previous exposure to systemic antitumor treatment or radiotherapy on the thoracicregion.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Esmolol Injection [Brevibloc]
Phase: 3
Study Start date:
April 18, 2023
Estimated Completion Date:
September 30, 2027

Study Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 10 days screening period to determine eligibility for study entry. At Baseline, patients who meet the eligibility requirements will be allocate in one of the 4 cohorts according to their medical conditions.

Trial design consists in a Screening period, Baseline, and 6 additional visits until Month-36.

All patients will undergo to a conventional echocardiography and echocardiography with esmolol administration at Baseline. This procedure will be performed at the following visits according their cohort.

Other complementary procedures will be the collection of blood samples to determine biomarkers, as well as hematology and biochemistry, vital signs and another explorations.

Connect with a study center

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d&#39;Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

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