Trial Title:
Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors
NCT ID:
NCT05699915
Condition:
Cancer
Immune-related Adverse Event
Cardiac Abnormalities, Variable
Immune Checkpoint Inhibitor-Related Myocarditis
Diastolic Dysfunction
Atherosclerosis
Cardiotoxicity
Conditions: Official terms:
Atherosclerosis
Cardiotoxicity
Myocarditis
Conditions: Keywords:
Cardio-oncology
Immune-related adverse event
Immune checkpoint inhibitor
Myocarditis
Troponin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cardiology consultation
Description:
- Electrocardiogram (ECG).
- Echocardiogram: A comprehensive evaluation of systolic and diastolic function,
ventricular and atrial geometry will be performed. Special attention will be given
to acquire a 3D measurement of left ventricular ejection fraction (LVEF) and to
perform deformation imaging of left ventricle (global longitudinal strain (GLS)).
The right ventricular function will be evaluated by tricuspid annular plane systolic
excursion (TAPSE) and peak systolic velocity S' derived from color coded tissue
Doppler imaging (TDI). Diastolic dysfunction will be based on average E/e' ratio >
15 and left atrial (LA) area > 30 cm2.
Arm group label:
Cancer patients with a solid tumour eligible for treatment with immune checkpoint inhibitors
Intervention type:
Diagnostic Test
Intervention name:
Chest Computed Tomography (CT) without contrast
Description:
Calcium score. This will be performed at baseline, 12 and 24 months. The scans at 12 and
24 months will be combined, if possible, with standard of care scans for cancer
treatment.
Arm group label:
Cancer patients with a solid tumour eligible for treatment with immune checkpoint inhibitors
Other name:
Cardiac CT
Intervention type:
Procedure
Intervention name:
Non-invasive endothelial function tests
Description:
- FMD
- PAT
This aspect of the study will only be performed in the patients included by the Antwerp
University Hospital due to organizational/practical issues.
Arm group label:
Cancer patients with a solid tumour eligible for treatment with immune checkpoint inhibitors
Other name:
Flow mediated dilatation (FMD)
Other name:
Peripheral arterial tonometry (PAT)
Intervention type:
Procedure
Intervention name:
Electrocardiogram
Description:
An ECG will be taken prior to each ICI cycle during the first three months of treatment.
Arm group label:
Cancer patients with a solid tumour eligible for treatment with immune checkpoint inhibitors
Other name:
ECG
Intervention type:
Diagnostic Test
Intervention name:
Extra serum sample (7.5 mL)
Description:
An extra serum sample will be taken at baseline, 3, 6, 12, 24 months and in case of
sudden cardiac problems. This will subsequently be analysed to determine high-sensitivity
troponin I, high-sensitivity troponin T and NT-proBNP.
Arm group label:
Cancer patients with a solid tumour eligible for treatment with immune checkpoint inhibitors
Summary:
The goal of this prospective, multicentre study is to investigate short- and long-term
cardiovascular effects in cancer patients treated with immune checkpoint inhibitors
(ICIs).
The main question[s] it aims to answer are:
- To investigate troponin and NT-proBNP values in patients receiving ICIs and their
association with ICI-induced CV abnormalities and MACEs.
- Study the calcium score, systolic, and diastolic (dys)function.
- Evaluate associations between patient/disease characteristics / transthoracic
echocardiography parameters / electrocardiography parameters and troponin /
NT-proBNP levels.
Participants will be closely monitored by performing the following additional visits and
testing:
- Chest CT scan prior to treatment start, after 12 and 24 months.
- Consultation with a cardiologist at baseline, 3, 6, 12 and 24 months, who will
perform an electrocardiogram and echocardiogram.
- One additional blood sample prior to treatment start, after 3, 6, 12 and 24 months.
An extra blood sample could be taken in case of sudden heart problems.
- Non-invasive endothelial function tests prior to treatment start, after 12 and 24
months.
Detailed description:
The increasing use of immune checkpoint inhibitors (ICIs) in the treatment of both
advanced and early stages of various malignancies has resulted in a substantial increase
in the incidence of cardiovascular immune related adverse events (irAEs). The current
guidelines are based on anecdotal evidence and expert opinions due to the lack of solid
data and prospective studies. Therefore, cardiac monitoring, in patients receiving ICIs,
is often not implemented by oncologists as many questions remain unanswered. Hence, the
urgent need to investigate the possible short and long term cardiovascular effects of
ICIs.
The investigators developed a multicentre, prospective study in which patients with a
solid tumour eligible for ICI treatment will be enrolled. The study exists of routine
investigations of blood parameters (troponin and (N-terminal) brain-type natriuretic
peptide levels in particular) and a thorough cardiovascular follow-up on fixed time
points during a period of two years. The cardiovascular follow-up consists of continuous
remote patient monitoring, routine cardiology consultations including electrocardiograms,
transthoracic echocardiograms, CT-scans for calcium scoring and non-invasive endothelial
function tests. Associations between these blood parameters and short and long term
cardiovascular irAEs will be statistically analysed.
This project will allow for a better estimate of the incidence of both short and
long-term cardiovascular irAEs in a 'real world' patient population receiving ICIs. If
the investigators are able to accurately predict and detect short- and long-term
cardiovascular irAEs in an early (and subclinical) stage by correct implementation and
interpretation of existing cardiac markers, they could be managed early on in a more
effective manner.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have a solid tumour and will receive one of the following therapies based on current
evidence based clinical guidelines: anti-programmed cell death protein-1 (PD-1),
anti-programmed cell death ligand-1 (PD-L1) and/or anti-cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) therapy
- Be literate in Dutch or English
Exclusion Criteria:
- Prior treatment with immunotherapy (immune checkpoint inhibitors, T-cell transfer
therapy, cancer treatment vaccines or immune system modulators).
- Patients who will receive ICIs in combination with an additional systemic
anti-cancer regimen (chemotherapy, tyrosine kinase inhibitors,...).
- Having a known history of human immunodeficiency virus (HIV) infection.
- Having a known history of hepatitis B (defined as hepatitis B surface antigen
[HBsAg] reactive) or known active hepatitis C virus (defined as detectable RNA via
qualitative nucleic acid testing) infection.
- Having a diagnosis of immunodeficiency or is receiving chronic/active systemic
steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AZ Sint-Vincentius Deinze
Address:
City:
Deinze
Zip:
9800
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Christof Vulsteke, Prof
Phone:
+3292469522
Email:
Christof.Vulsteke@azmmsj.be
Facility:
Name:
Algemeen Ziekenhuis Maria Middelares
Address:
City:
Ghent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Christof Vulsteke, Prof
Phone:
+3292469522
Email:
Christof.Vulsteke@azmmsj.be
Contact backup:
Last name:
Danielle Delombaerde, PharmD
Phone:
+3292469511
Email:
Danielle.Delombaerde@azmmsj.be
Facility:
Name:
AZ Sint-Elisabeth Zottegem
Address:
City:
Zottegem
Zip:
9620
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Christof Vulsteke, Prof
Phone:
+3292469522
Email:
Christof.Vulsteke@azmmsj.be
Facility:
Name:
Antwerp University Hospital
Address:
City:
Antwerp
Zip:
2650
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Hans Prenen, Prof
Email:
Hans.Prenen@uza.be
Contact backup:
Last name:
Sanne Wouters
Phone:
+32 3 821 24 41
Email:
Sanne.Wouters@uza.be
Investigator:
Last name:
Hans Prenen, Prof
Email:
Principal Investigator
Investigator:
Last name:
Constantijn Franssen, Dr
Email:
Sub-Investigator
Start date:
January 7, 2022
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Algemeen Ziekenhuis Maria Middelares
Agency class:
Other
Source:
Algemeen Ziekenhuis Maria Middelares
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05699915
