Primary Objective:Register the incidence of cardiovascular toxicity of anticancer treatment.Secondary Objectives: Identification of risk factors for cardiotoxicity.Improvement in the early detection of cardiotoxicity by imaging modalities such as…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
Register the incidence of cardiovascular toxicity of anticancer treatment.
Secondary outcome
Secondary Objectives:
Identification of risk factors for cardiotoxicity.
Improvement in the early detection of cardiotoxicity by imaging modalities such
as echocardiography (or even cardiac CT or cardiac MRI when available).
Describe long-term outcomes of patients that received anticancer regimens.
Describe therapeutic approaches currently used in the treatment of cancer
therapy-related cardiac dysfunction.
Background summary
Advances in the early detection and treatment of cancer has led to increasing
numbers of cancer survivors worldwide [1,2]. Nonetheless, despite this
considerable progress, short- and long-term side effects of anticancer
treatment can significantly affect patient survival and quality of life.
Cardiovascular diseases are one of the most frequent side effects, and can
manifest in many forms such as heart failure, arrhythmias, valvular-,
pericardial- and coronary artery disease.
Since the late *90s, the attention for these cardiovascular side effects has
grown and led to increased knowledge of pathophysiological mechanisms,
diagnostics- and treatment of cardiotoxicity. Following this increasing
awareness, the ESC published a position paper on cancer treatments and
cardiovascular toxicity in 2016, which provides an overview of cardiovascular
monitoring and decision-making in patients treated with potentially cardiotoxic
regimens [3]. Despite these advantages, there are still many important
unresolved issues and challenges within the field of cardio-oncology and an
evidence-based clinical guideline on cardio-oncological care is currently
lacking.
The DUTCH CARDIOTOX REGISTRY is a prospective multicentre registry in which
clinical information of patients visiting cardio-oncology units across the
Netherlands will be collected including a biobank and an imaging bank. The
primary objective is to register the incidence of cardiovascular toxicity of
cancer treatment. Secondary objectives includes the identification of risk
factors for cardiotoxicity [4]. Imaging modalities, such as echocardiography
will be analysed to develop methods for the early detection of (subclinical)
cardiotoxicity. Additionally, the registry provides a platform for future
(interventional) studies.
The ultimate goal of the DUTCH CARDIOTOX REGISTRY is to improve
cardio-oncological care and improve quality of life and cardiovascular
prognosis in patients treated for their malignancy.
Study objective
Primary Objective:
Register the incidence of cardiovascular toxicity of anticancer treatment.
Secondary Objectives:
Identification of risk factors for cardiotoxicity.
Improvement in the early detection of cardiotoxicity by imaging modalities such
as echocardiography (or even cardiac CT or cardiac MRI when available).
Describe long-term outcomes of patients that received anticancer regimens.
Describe therapeutic approaches currently used in the treatment of cancer
therapy-related cardiac dysfunction.
Study design
The DUTCH CARDIOTOX REGISTRY is a prospective multicentre observational cohort
study of patients presenting at specialized cardio-oncology units in Dutch
hospitals which will also encompass a biobank as well as an imaging bank. The
registry is intended as a long-term - ideally permanent - registry. The
estimated number of participants is at least 400 per year.
Study burden and risks
We do not anticipate adverse events from participating to the study itself
except possibly bleeding due to collection of blood samples.
Dr Molenwaterplein 40
Rotterdam 3015 GD
NL
Dr Molenwaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
To be eligible participating in this study, patients must meet all the
following criteria:
• Patients who visit a specialized cardio-oncology unit.
• Age >=18 years.
• Written informed consent.
Exclusion criteria
To improve the precision of cardiotoxicity definitions, patients with
pre-existing symptomatic heart failure or left ventricular ejection fraction
(LVEF) <40%, patients in whom baseline biomarkers and/or baseline
echocardiographic data were not complete and those who died within 3 months
will be excluded.
Conditions that affect a patient*s ability to provide written informed consent,
such as psychiatric or mental disorders, language barriers or other factors.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80281.078.22 |