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Clinical Trials/NCT04461392
NCT04461392
Unknown
Not Applicable

Role of Myocardial Work in the Prediction of Cardiac Dysfunction and Response After Revalidation in Patients With Cancer Undergoing Chemotherapy and/or Radiotherapy

Universitair Ziekenhuis Brussel1 site in 1 country191 target enrollmentAugust 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oncology
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
191
Locations
1
Primary Endpoint
Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope
Last Updated
5 years ago

Overview

Brief Summary

This study regarding oncological patients for rehabilitation after specific cancer therapy involves three aims: (1) to evaluate the predictive value of myocardial work parameters on the improvement of exercise performance after rehabilitation, (2) to determine which echocardiographic parameters are more suitable in predicting cardiac dysfunction, and (3) to evaluate the correlation between echocardiographic parameters and fibrosis detected by cardiac magnetic resonance imaging (CMR).

Detailed Description

Myocardial work (MW) provides an estimation of cardiac function by combining global longitudinal strain (GLS) with blood pressure values obtained non-invasively, being less load dependent than standard GLS. The investigator hypothesize that myocardial work could be a useful marker for predicting the exercise performance after chemotherapy and/or radiotherapy in oncological patients undergoing rehabilitation. Moreover, this study may provide additional information in optimal selection for rehabilitation programs.

Registry
clinicaltrials.gov
Start Date
August 2020
End Date
August 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bernard Cosyns

Head of Department

Universitair Ziekenhuis Brussel

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with cancer
  • Undergoing chemotherapy and/or radiotherapy/hormone therapy
  • Age older than 18 years old - maximum age of 90 years old
  • Willing to enter revalidation in Universitair Ziekenhuis Brussel
  • Signed consent form

Exclusion Criteria

  • Severe aortic stenosis defined as aortic valve aria under 0.6 cm2/m2
  • Supraventricular arrhythmias
  • Poor image quality for 2D and 3D echocardiography defined as the impossibility to examine of more than 2 adjacent segments
  • Resistant hypertension defined as uncontrolled blood pressure values under current European guidelines, Systolic Blood Pressure more than 140 mmHg and/or Diastolic Blood Pressure more than 80 mmHg
  • Lung cancer

Outcomes

Primary Outcomes

Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope

Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)

this parameter shows the increase in ventilation in response to CO2 production, thus it measures the ventilatory efficiency

Change in peak volume oxygen - VO2 (L/min)

Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)

represents the maximum oxygen consumption during incremental exercise that is measured during Cardiopulmonary Exercise test (CPET), being a measure of aerobic capacity of the subject

Change in the respiratory exchange ratio (RER)

Time Frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)

represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort

Secondary Outcomes

  • Change in myocardial work (MW)(change from baseline (before rehabilitation) at 15 months (after rehabilitation))
  • Change in health status(change from baseline (before rehabilitation) at 15 months (after rehabilitation))
  • Major adverse cardiovascular events (MACE)(through study completion, an average of 1 year)

Study Sites (1)

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