Evolution of the Heart Function When Monitoring Immunotherapies Anti-cancerous Inhibiting PD-1

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Enrolling

Phase 4

Conditions

Melanoma

Non-small Cell

Lung Cancer

Treatments

Drug: Nivolumab

Device: trans-thoracic echocardiography

Device: MRI

Biological: BLOOD SAMPLES

Study type

Interventional

Funder types

Other

Identifiers

NCT03313544

2017-01

2017-001197-42 (EudraCT Number)

Details and patient eligibility

About

Prospective, monocentric clinical study. Patients selected for nivolumab therapy in AP-HM for melanoma and non-small cell lung cancer will be eligible. Do not include patients with conditions that do not allow MRI, prior cardiovascular disease with LVEF<50%, cardiomyopathy, history of cardiac arrhythmia, history of cardiovascular toxicity under anticancer therapy, coronary artery disease or stroke less than 3 months Therapeutic management will not be modified and treatment will be administrated as usual.

Cardiovascular follow up will be identical to that recommended and realized in current care in the Cardio-Oncology unit of AP-HM. It will include clinical, biological (BNP and troponin) and trans-thoracic echocardiography (TTE) at baseline and then at 1, 3 and 6 months. Auto-antibodies against troponin I assay will be performed to avoid false negatives of normal blood level of troponin I at baseline and then at 6 months. Cardiac MRI will be performed as well at baseline and at the end of the study (6 months). MRI is the gold standard for ventricular function evaluation.

Primary endpoint will be left ventricular function evolution evaluated by global longitudinal strain (GLS, 2D speckles tracking) in TTE. Secondary endpoints will be left and right ventricular function parameters: LEVF by TTE and MRI, left ventricular indexed volumes by TTE and MRI, right ejection ventricular function and indexed volumes by TTE and MRI, systolic pulmonary arterial pressure by TTE, serum troponin I and BNP, arrhythmias and conduction disorders on the electrocardiogram (ECG).

Number of required subjects: GLS is recommended for following up left ventricular function under anticancer treatments. Based on the hypothesis of a significant GLS decrease (15%) in 20% of cases with alpha risk of 0.05 and accuracy of 0.12 which means expected confidence interval of 0.08-0.32, then the number of required subjects is 50 patients.

The inclusion period will be 18 months with a follow up if 6 months, ie a total duration of the study of 24 months.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients treated with nivolumab

Exclusion criteria

Age <18 years
Preliminary cardiac disease with FeVG <50%
Cardiomyopathy dilated, hypertrophic or restrictive
History of cardiac arrhythmia
History of cardiac toxicity under another anti-cancer treatment
Known coronary disease
History of stroke less than 3 months old
Patient not wishing to participate in the study
Vulnerable persons (pregnant women, adults under guardianship or guardianship, persons deprived of their liberty)