Cardiomyopathy and heart failure risk after treatment for Hodgkin lymphoma or aggressive B cell non-Hodgkin lymphoma

Conditions: cardiomyopathy
Heartfailure
10025323
10019280

Registration Number: NL-OMON50135

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 800

Inclusion Criteria

All lymphoma survivors who meet the inclusion criteria of the P11CHT study or
the CRYSTAL cohort study are eligible for the CRYSTAL case-control study. The
most important inclusion criteria for the P11CHT and CRYSTAL cohort study are:
* Diagnosis of Hodgkin's lymphoma (P11CHT) or aggressive B-cell non-Hodgkin's
lymphoma (CRYSTAL cohort)
* Treatment for the lymphoma between 1965 and 2005 (P11CHT) or between 1989 and
2012 (CRYSTAL cohort)
* Age at diagnosis <51 years (P11CHT) or <61 years (CRYSTAL cohort)
* Still alive at least 5 years after primary lymphoma treatment

Exclusion Criteria

* A history of (symptomatic) myocardial infarction, valvular heart disease,
cardiomyopathy or heart failure before lymphoma diagnosis
* Chemotherapy or immunotherapy for a primary malignancy before lymphoma
diagnosis
* Radiotherapy to the trunk before lymphoma diagnosis
* Myocardial infarction or *CTCAE grade 2 valvular heart disease prior to
diagnosis of cardiomyopathy or heart failure
* Insufficient understanding of the Dutch language (for survivors receiving the
questionnaire)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cardiomyopathy and congestive heart failure will be graded according to the<br /><br>Common Terminology Criteria for Adverse Events, version 4.0. Treatment<br /><br>histories of cases and controls will be compared using conditional logistic<br /><br>regression models. We will specifically focus on exposure distributions,<br /><br>cumulative drug dose for each cytostatic drug used (specifically doxorubicin,<br /><br>cyclophosphamide and rituximab) and mediastinal irradiation. The effect of<br /><br>cardiovascular risk factors such as hypertension, hypercholesterolemia,<br /><br>diabetes mellitus type II, smoking and family history of cardiovascular<br /><br>diseases will also be evaluated. Radiation charts and simulation radiographs<br /><br>will be used to estimate mean heart dose (MHD) and the radiation dose-response<br /><br>relationship will be modelled. Blood samples will be used for examination of<br /><br>susceptibility genes for anthracycline and/or radiation induced CVDs. </p><br>

Secondary Outcome Measures