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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
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).
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain
RECRUITINGHospital Clínic de Barcelona
Barcelona, Barcelona, Spain
NOT_YET_RECRUITINGHospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
RECRUITINGHospital Universitario La Paz
Madrid, Madrid, Spain
RECRUITINGHospital Clínico Universitario de Salamanca
Salamanca, Salamanca, Spain
RECRUITINGHospital Universitari i Politècnic La Fe
Valencia, Valencia, Spain
NOT_YET_RECRUITINGLeft Ventricle (LV) ejection fraction
Estimated with 3D echocardiography (Both: convectional and with esmolol administration)
Time frame: 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)
Time frame: 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)
Time frame: At Baseline (Day 1) until Month-24 according to cohort
Ejection fraction
Obtained with 2D echocardiography (Simpson's biplane method)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Baseline (Day 1) until Month-24 according to cohort
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