Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma

Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Complete echocardiographic assessment including 2-dimension global longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. The aim of Cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2D-GLS.

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Key information

Conditions

Lymphoma, Non-Hodgkin Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Toxicity, Cardiac Wounds and Injuries

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Ematologia - AOU Città della salute e della Scienza di Torino

Torino, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18 years
Diagnosis of Hodgkin Disease (HD) or Primary Mediastinal B-cell lymphoma (PMBCL) or diffuse large B-cell lymphoma (DLBCL)
Disease requiring treatment with anthracycline containing regimen only (cohort A) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort B)
Written informed consent

Exclusion criteria

Age > 70 years
Unable to perform anthracyline containing regimen
Previous treatment with mediastinal radiotherapy
Kidney failure (defined as creatinine x2 UNL) or liver failure (defined as AST and ALT x2 UNL)
ECOG PS > 2
Echocardiographic acoustic windows not suitable for strain evaluation
Any other conditions or situations preventing patients to sign informed consent

Treatment and study plan

Primary outcomes

Left ventricular ejection fraction (LVEF)

Time frame: Baseline, Change of LVEF from Baseline at 4/6 month (end of chemotherapy), Change of LVEF from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of LVEF from Baseline at 9/11 months (3 months after treatment completion)

Left ventricular ejection fraction measured by echocardiography
Global Longitudinal Strain (GLS)

Time frame: Baseline, Change of GLS from Baseline at 4/6 month (end of chemotherapy), Change of GLS from Baseline at 6/8 months (end of radiotherapy - if applicable), Change of GLS from Baseline at 9/11 months (3 months after treatment completion)

Global Longitudinal Strain measured by strain-rate echocardiography

Secondary outcomes

Anthracycline cumulative dose

Time frame: 4/6 month after baseline (end of chemotherapy)

Anthracycline cumulative dose
T troponin

Time frame: Baseline, Before each chemotherapy administration, 4/6 month after baseline (end of chemotherapy), 6/8 months after baseline (end of radiotherapy - if applicable), 9/11 months after baseline (3 months after treatment completion)

T troponin rate

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Acronym: Cardiocare

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Mar 29, 2018
Registry last updated: Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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