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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03480087

Acronym

Cardiocare

Enrollment

118

Registered

2018-03-29

Start date

2015-01-31

Completion date

2022-07-31

Last updated

2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma, Lymphoma, Non-Hodgkin, Toxicity, Cardiac

Keywords

strain-rate echocardiography, chemotherapy, radiotherapy, mediastinal, Lymphoma, Hodgkin

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Left ventricular ejection fraction (LVEF)	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)	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

Measure	Time frame	Description
Anthracycline cumulative dose	4/6 month after baseline (end of chemotherapy)	Anthracycline cumulative dose
T troponin	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

Countries

Italy

Outcome results