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Tests treatment safety and results for Cirrhosis
Official title Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments
ClinicalTrials.gov ID: NCT05769868
What this study is testing
What is Esmolol Injection [Brevibloc]?
Esmolol Injection [Brevibloc] is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cirrhosis.
Also referred to as Anatomical Therapeutic Chemical (ATC) code: C07AB09, Esmolol Hydrochloride.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years.
- Absence of previous heart disease, defined as the absence of relevant cardiac structural alterations such as moderate or severe hypertrophy...
- 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.
- Diabetic patients with a diagnosis of Diabetes Mellitus 2 (DM2) with or without Heart Failure with Normal Ejection Fraction (HFNEF) (n = 300) will be...
You likely can't join if
- Contraindication for the administration of esmolol (according to technical data sheet): Hypersensitivity to esmolol hydrochloride; Severe sinus...
- 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...
- History of previous high-grade atrioventricular (AV) conduction disorder in non-pacemaker patients.
- Severe asthma with bronchial hyperresponsiveness.
- Patients with acute infection.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- Expected survival\> 6 months, first-diagnosis of cancer, and receiving treatment with chemotherapy that includes any of the previous schemes.
- A control group (n = 200) without heart disease and without any of the study conditions will be included: diabetes from any cause, cancer or active cancer treatment or some degree of liver disease.
- 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...
- 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.
- 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.
- 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, Latent Autoimmune 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 advanced heart failure.
- Treatment with an oral beta-blocker at the time of the examination that cannot be safely 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 or localized cancers treated locally surgically).
- Previous exposure to systemic antitumor treatment or radiotherapy on the thoracic region.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
- Madrid, Madrid, Spain
- Salamanca, Salamanca, Spain
- Valencia, Valencia, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain; Madrid, Madrid, Spain; Salamanca, Salamanca, Spain; Valencia, Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.