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

Completed

• Conditions: Lymphoma, Non-Hodgkin; Hodgkin Lymphoma; Toxicity, Cardiac

• Registration Number: NCT03480087
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-29
• Status Verified: 2022-07
• Primary Completion: 2022-07
• Study Completion: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Anthracycline cumulative dose	4/6 month after baseline (end of chemotherapy)	Anthracycline cumulative dose

Trial Locations

Locations (1)

SC Ematologia - AOU Città della salute e della Scienza di Torino; 🇮🇹 Torino, Italy