RecruitingCirrhosisDiabetes MellitusOncologic Disorders
Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)
You may qualify if…
- ✓ 1. Age ≥ 18 years.
- ✓ 2. 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.
- ✓ 3. Existence of an at least acceptable ultrasonic window, which allows the visualization 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 without Heart 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 be included: Child-Pugh A class (n = 25); Child-Pugh B class (n = 75); Child-Pugh C class (with and without ascites n = 50 and n = 50, respectively).
- ✓ 7. 300 cancer patients will be included, divided into 3 therapeutic groups: 125 patients diagnosed with Lymphoma or Sarcoma receiving chemotherapy based on anthracyclines at high doses (≥ 240 mg / m2); 125 patients with Human Epidermal growth factor Receptor 2 (HER2) positive breast cancer receiving chemotherapy regimen that includes trastuzumab without anthracyclines; 50 patients with hepatocarcinoma receiving treatment with Sorafenib.
- ✓ 8. Expected survival\> 6 months, first-diagnosis of cancer, and receiving treatment with chemotherapy that includes any of the previous schemes.
You may not qualify if…
- ✕ 1. 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.
- ✕ 2. Treatment with beta-blocker drugs (oral, topical or intravenous) in the last 7 days before the study.
- ✕ 3. History of ventricular or supraventricular arrhythmias that prevent the safe withdrawal of antiarrhythmic or braking treatment before the administration of esmolol.
- ✕ 4. History of previous high-grade atrioventricular (AV) conduction disorder in non-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 the study.
- ✕ 8. Pregnant women, or who plan to be, and women during breastfeeding.
Source: ClinicalTrials.gov · NCT05769868 · last updated 2024-10-01