Doppler-derived ejection intraventricular pressure gradients provide a reliable assessment of left ventricular systolic chamber function.
Raquel Yotti, Javier Bermejo, M Mar Desco...
https://pubmed.ncbi.nlm.nih.gov/16172285/Actively Recruiting
Led by Consorcio Centro de Investigación Biomédica en Red (CIBER) · Updated on 2024-10-01
1000
Participants Needed
6
Research Sites
26 weeks
Total Duration
Researchers are evaluating how well esmolol echocardiography works compared to conventional echocardiography in detecting early heart problems related to type 2 diabetes, liver cirrhosis, and cancer treatments that can affect the heart. This phase 3, open, multicenter study aims to find out if esmolol can better identify subtle heart changes before symptoms appear, helping improve diagnosis for these conditions. The study includes a 10-day screening period, followed by baseline assessments and six additional visits over 36 months. Participants will undergo both conventional echocardiography and echocardiography with esmolol given through an intravenous infusion. Esmolol dosing starts with a loading dose followed by maintenance infusion, adjusted to achieve a specific heart rate reduction. Blood samples will be collected at various visits to measure biomarkers, along with routine blood tests and vital sign monitoring. Participants will be assessed regularly with imaging and laboratory tests to measure heart function, including left ventricle ejection fraction and strain, along with biomarkers linked to heart health and inflammation. The study tracks these outcomes from baseline up to 24 months, depending on the participants group. Safety and health status will be monitored throughout the study period, which lasts up to three years from enrollment.
CONDITIONS
Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments
T
Tania Luis García, BS
P
Projects Department (CIBER)
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Consorcio Centro de Investigación Biomédica en Red (CIBER)
Lead Sponsor
Instituto de Salud Carlos III
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 10 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants who meet eligibility requirements undergo baseline assessments including conventional echocardiography and echocardiography with esmolol administration, blood sample collection for biomarkers, hematology and biochemistry, vital signs, and other explorations.
1 visit (in-person)
Duration - Up to 36 months
Participants receive echocardiography with esmolol administration and undergo repeated assessments including blood sample collection, hematology and biochemistry, vital signs, and other explorations according to their cohort assignment.
6 additional visits until Month 36
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Raquel Yotti, Javier Bermejo, M Mar Desco...
https://pubmed.ncbi.nlm.nih.gov/16172285/Raquel Yotti, Cristina Ripoll, Yolanda Benito...
https://pubmed.ncbi.nlm.nih.gov/28195341/Raquel Yotti, Javier Bermejo, Yolanda Benito...
https://pubmed.ncbi.nlm.nih.gov/24173273/Consorcio Centro de Investigación Biomédica en Red (CIBER)
Lead Sponsor
Instituto de Salud Carlos III
Collaborating Sponsor