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RECRUITING
NCT05769868
PHASE3

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

Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)

View on ClinicalTrials.gov

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.

Official title: Prospective, Multicenter and Open Study to Evaluate the Efficacy of Esmolol in the Early Identification of Cardiovascular Disorders Induced by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2023-04-18

Completion Date

2027-09

Last Updated

2024-10-01

Healthy Volunteers

Yes

Interventions

DRUG

Esmolol Injection [Brevibloc]

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).

Locations (6)

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain