Actively Recruiting

Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT05769868

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

Led by Consorcio Centro de Investigación Biomédica en Red (CIBER) · Updated on 2024-10-01

1000

Participants Needed

6

Research Sites

228 weeks

Total Duration

On this page

Sponsors

C

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Lead Sponsor

I

Instituto de Salud Carlos III

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • No prior heart disease including significant structural heart changes or severe valve disease
  • Adequate ultrasound window allowing visualization of most left ventricle segments
  • Sinus rhythm with resting heart rate above 50 bpm
  • Diabetes Mellitus type 2 patients with or without stable heart failure with normal ejection fraction
  • Patients with cirrhosis classified by Child-Pugh scores A, B, or C with or without ascites
  • Cancer patients receiving specified chemotherapy regimens including anthracyclines, trastuzumab, or sorafenib
  • Expected survival over 6 months with first cancer diagnosis and ongoing specified treatment
  • Control group without heart disease, diabetes, cancer, or liver disease
Not Eligible

You will not qualify if you...

  • Contraindications to esmolol such as severe bradycardia, atrioventricular block without pacemaker, cardiogenic shock, severe hypotension, decompensated heart failure, untreated pheochromocytoma, or acute asthma attack
  • Beta-blocker use within 7 days before study
  • History of arrhythmias preventing safe medication withdrawal
  • Previous high-grade atrioventricular block without pacemaker
  • Severe asthma with bronchial hyperresponsiveness
  • Acute infection
  • Participation in other clinical trials within 30 days before study
  • Pregnancy or breastfeeding
  • Inability to follow study protocol
  • Diabetes types other than type 2
  • Advanced heart failure (NYHA class IV)
  • Oral beta-blocker treatment that cannot be safely stopped 72 hours before testing
  • Active hepatitis B or C infection
  • Previous cancer requiring systemic treatment (except certain skin or localized cancers)
  • Prior systemic cancer treatment or thoracic radiotherapy exposure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain, 08035

Actively Recruiting

2

Hospital Clínic de Barcelona

Barcelona, Barcelona, Spain, 08036

Not Yet Recruiting

3

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain, 28007

Actively Recruiting

4

Hospital Universitario La Paz

Madrid, Madrid, Spain, 28046

Actively Recruiting

5

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain, 37007

Actively Recruiting

6

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain, 46026

Not Yet Recruiting

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Research Team

T

Tania Luis García, BS

CONTACT

P

Projects Department (CIBER)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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