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CompletedNCT03480087CardiocareUpdated Jul 19, 2022

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

An observational study in Lymphoma, Non-Hodgkin, Hodgkin Lymphoma and Toxicity, Cardiac, sponsored by A.O.U. Città della Salute e della Scienza. Completed at 1 site in Italy. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-19.

Sponsored by A.O.U. Città della Salute e della Scienza · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
118
Ages
19 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • strain-rate echocardiography
  • chemotherapy
  • radiotherapy, mediastinal
  • Lymphoma
  • Hodgkin
03

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient 19-70 years old with HD or PMBCL or DLBCL requiring treatment with chemotherapy or chemotherapy plus mediastinal radiotherapy suitable for a strain-rate echocardiograpy evaluation

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
118 participants (actual)
Patient registry
No

Groups and cohorts

  • Chemotherapy alone

    Patient treated with anthracycline containing chemotherapy

  • Chemotherapy plus radiotherapy

    Patient treated with anthracycline containing chemotherapy followed by mediastinal radiotherapy

05

What researchers measure

Primary outcomes

  1. Left ventricular ejection fraction (LVEF)

    Left ventricular ejection fraction measured by echocardiography

    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)

  2. Global Longitudinal Strain (GLS)

    Global Longitudinal Strain measured by strain-rate echocardiography

    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)

Secondary outcomes

  1. Anthracycline cumulative dose

    Anthracycline cumulative dose

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

  2. T troponin

    T troponin rate

    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)

06

Study locations

1 site
  • SC Ematologia - AOU Città della salute e della Scienza di Torino
    Torino, 10126, Italy
07

Registry details

Key details

Study ID
NCT03480087
Lead sponsor
A.O.U. Città della Salute e della Scienza
Responsible party
Mario Levis (Medical doctor, A.O.U. Città della Salute e della Scienza) — Principal investigator
First posted
Mar 29, 2018
Start date
Jan 2015
Primary completion
Jul 2022
Completion
Jul 2022
Last update
Jul 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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