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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003889-12 | EudraCT Number |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | 1 conventional echocardiography without esmolol administration followed by 1 echocardiography with esmolol administration at Baseline and other study visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esmolol Injection [Brevibloc] | Drug | Brevibloc® will be administered intravenously by infusion pump following the administration schedule: Loading dose of 500 μg/kg for 1 minute, followed by a maintenance infusion of 50 μg/kg/minute over 5 minutes. If the target response is not obtained, the loading dose is repeated and the 50 dose is increased by 50 μg/kg/minute to a maximum of 200 μg/kg/minute. The objective response to esmolol beta-blockade is defined as a 15-20% reduction in heart rate, with lower limits of 55 bpm and a systolic blood pressure not less than 90 mmHg and diastolic blood pressure not less than 50 mmHg. The perfusion is kept active while the echocardiography image acquisition is completed (approx. 15-30 min). |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricle (LV) ejection fraction | Estimated with 3D echocardiography (Both: convectional and with esmolol administration) | At Baseline (Day 1) until Month-24 according to cohort |
| Peak measurement of global LV systolic longitudinal strain | Estimated with 3D echocardiography (Both: convectional and with esmolol administration) | At Baseline (Day 1) until Month-24 according to cohort |
| Ejection Intraventricular Pressure Difference (EIVPD) measure | Estimated with M-mode echocardiography (Both: convectional and with esmolol administration) | At Baseline (Day 1) until Month-24 according to cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Ejection fraction | Obtained with 2D echocardiography (Simpson's biplane method) | At Baseline (Day 1) until Month-24 according to cohort |
| Interleukin (IL)-1β | Biochemical variables in blood in relation to the alteration of the different components of the myocardium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tania Luis García, BS | Contact | +34 917996034 | 47304 | tanialuisgarcia@cibercv.es |
| Projects Department (CIBER) | Contact | +34 918222874 | proyectos@ciberisciii.es |
| Name | Affiliation | Role |
|---|---|---|
| Javier Bermejo Thomas, MD, PhD | Hospital Universitario Gregorio Marañón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24173273 | Background | Yotti R, Bermejo J, Benito Y, Sanz-Ruiz R, Ripoll C, Martinez-Legazpi P, del Villar CP, Elizaga J, Gonzalez-Mansilla A, Barrio A, Banares R, Fernandez-Aviles F. Validation of noninvasive indices of global systolic function in patients with normal and abnormal loading conditions: a simultaneous echocardiography pressure-volume catheterization study. Circ Cardiovasc Imaging. 2014 Jan;7(1):164-72. doi: 10.1161/CIRCIMAGING.113.000722. Epub 2013 Oct 30. | |
| 16172285 |
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| At Baseline (Day 1) until Month-24 according to cohort |
| High-sensitivity IL-6 (hsIL-6) | Biochemical variables in blood in relation to the alteration of the different components of the myocardium | At Baseline (Day 1) until Month-24 according to cohort |
| Soluble Suppression of Tumorigenicity 2 (ST-2) | Biochemical variables in blood in relation to the alteration of the different components of the myocardium | At Baseline (Day 1) until Month-24 according to cohort |
| N-terminal fragment of brain natriuretic peptide (NT-proBNP) | Biochemical variables in blood in relation to the alteration of the different components of the myocardium | At Baseline (Day 1) until Month-24 according to cohort |
| Ultrasensitive troponin I (hsTnI) | Biochemical variables in blood in relation to the alteration of the different components of the myocardium | At Baseline (Day 1) until Month-24 according to cohort |
| Procollagen type I terminal propeptide (PICP) | Biochemical variables in blood in relation to the alteration of the different components of the myocardium | At Baseline (Day 1) until Month-24 according to cohort |
| C-terminal telopeptide collagen type I (CITP) | Biochemical variables in blood in relation to the alteration of the different components of the myocardium | At Baseline (Day 1) until Month-24 according to cohort |
| Matrix metalloproteinase-1 (MMP-1) | Biochemical variables in blood in relation to the alteration of the different components of the myocardium | At Baseline (Day 1) until Month-24 according to cohort |
| Hospital Clínic de Barcelona | Not yet recruiting | Barcelona | Barcelona | 08036 | Spain |
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| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | Madrid | 28007 | Spain |
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| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
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| Hospital Clínico Universitario de Salamanca | Recruiting | Salamanca | Salamanca | 37007 | Spain |
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| Hospital Universitari i Politècnic La Fe | Not yet recruiting | Valencia | Valencia | 46026 | Spain |
|
| Background |
| Yotti R, Bermejo J, Desco MM, Antoranz JC, Rojo-Alvarez JL, Cortina C, Allue C, Rodriguez-Abella H, Moreno M, Garcia-Fernandez MA. Doppler-derived ejection intraventricular pressure gradients provide a reliable assessment of left ventricular systolic chamber function. Circulation. 2005 Sep 20;112(12):1771-9. doi: 10.1161/CIRCULATIONAHA.104.485128. |
| 28195341 | Background | Yotti R, Ripoll C, Benito Y, Catalina MV, Elizaga J, Rincon D, Fernandez-Aviles F, Bermejo J, Banares R. Left ventricular systolic function is associated with sympathetic nervous activity and markers of inflammation in cirrhosis. Hepatology. 2017 Jun;65(6):2019-2030. doi: 10.1002/hep.29104. Epub 2017 Apr 28. |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C036604 | esmolol |
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