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

Sponsor
Assistance Publique Hopitaux De Marseille
Study ID
NCT03313544
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    NIVOLUMAB
  • MRI — DEVICE
    Cardiac MRI 6 MONTHS
  • BLOOD SAMPLES — BIOLOGICAL
    biological (BNP and troponin)
  • trans-thoracic echocardiography — DEVICE
    1, 3 and 6 months

Study Details

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.

Key Dates

Start date
Apr 9, 2018
Status verified
Apr 2023
Primary completion
Oct 31, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: NIVOLUMAB PATIENTS

Primary Outcome Measure

systolic pulmonary arterial pressure [ Time Frame: 6 months ]

Central Contacts

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