Clinical trial NCT04461392: Exercise Response After Revalidation in Cancer Patients
Official title: Role of Myocardial Work in the Prediction of Cardiac Dysfunction and Response After Revalidation in Patients With Cancer Undergoing Chemotherapy and/or Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oncology
Cardiac Toxicity
Keywords: Echocardiography
Revalidation
Cardiovascular magnetic resonance imaging
Oncology
Radiotherapy
Chemotherapy
Cardiorespiratory exercise test
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Severe aortic stenosis defined as aortic valve aria under 0.6 cm2/m2
2. Supraventricular arrhythmias
3. Poor image quality for 2D and 3D echocardiography defined as the impossibility to examine of more than 2 adjacent segments
4. 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
5. Lung cancer

Primary outcomes:
measure: Change in peak volume oxygen - VO2 (L/min)
timeFrame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
measure: Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope
timeFrame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
measure: Change in the respiratory exchange ratio (RER)
timeFrame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
Secondary outcomes:
measure: Change in myocardial work (MW)
timeFrame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
measure: Change in health status
timeFrame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
measure: Major adverse cardiovascular events (MACE)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Bernard Cosyns, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Schrub F, Schnell F, Donal E, Galli E. Myocardial work is a predictor of exercise tolerance in patients with dilated cardiomyopathy and left ventricular dyssynchrony. Int J Cardiovasc Imaging. 2020 Jan;36(1):45-53. doi: 10.1007/s10554-019-01689-4. Epub 2019 Sep 12.
citation: Galli E, Vitel E, Schnell F, Le Rolle V, Hubert A, Lederlin M, Donal E. Myocardial constructive work is impaired in hypertrophic cardiomyopathy and predicts left ventricular fibrosis. Echocardiography. 2019 Jan;36(1):74-82. doi: 10.1111/echo.14210. Epub 2018 Nov 29.
citation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
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