Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)

Study Overview
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Brief Summary
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The CARTIER study is a randomized, multicenter, open-label clinical trial comparing, in elderly patients with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies: primary (intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care) vs. secondary (current clinical practice where intensive cardiovascular monitoring is not routinely performed and cardiotoxicity patient care is based on the onco-hematologist criteria). The primary endpoint is to determine whether this primary prevention englobing cardiovascular monitoring plus intensive multidisciplinary management is superior to the current clinical practice in reducing all cause mortality. Other secondary objectives of the study are to analyze the impact of this intensive cardiovascular monitoring strategy on the incidence of cardiovascular mortality, oncological mortality, hospitalization and/or urgent care due to cardiovascular complications, hospitalization and/or urgent oncological care due to cancer complications, tumor progression and cost-effectiveness analysis. A total of 514 patients ≥ 65 years old diagnosed with any of the following onco-hematological cancers, colon, breast, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia or myeloma, undergoing standardized anti-tumoral treatment, will be recruited. The incidence of primary and secondary outcomes will be measured at 2 and 5 years

Official Title
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Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies

Conditions
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Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Elderly, Antineoplastic Agents, Cardiotoxicity

Intervention / Treatment
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* Other: Intensive cardiovascular monitoring
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 65 years old Expected survival >1 year Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma Signature on the informed consent Exclusion Criteria: Patients included in clinical trials will be excluded if they interfere with the CARTIER follow-up protocol. If they do not interfere they can be included Patients who had received previous potentially cardiotoxic anticancer treatment

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary prevention strategy<br>Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care. | Other: Intensive cardiovascular monitoring<br>* Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study.<br>|
| Other: Secondary prevention strategy (control)<br>Current clinical practice: cardiac care is based on the onco-hematologist criteria. | Other: No intervention<br>* Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years). Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Cumulative incidence of all-cause mortality | Two (mid-term analysis) and five years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological mortality | Cumulative incidence of oncological mortality | Two and five years of follow-up | 
| Cardiovascular mortality | Cumulative incidence of cardiovascular mortality | Two and five years of follow-up | 
| Hospitalization | Cumulative incidence of hospitalization | Two and five years of follow-up | 
| Hospitalization/emergency cardiovascular cause | Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause | Two and five years of follow-up | 
| Hospitalization/emergency cancer cause | Cumulative incidence of hospitalization and/or emergency care for cancer cause | Two and five years of follow-up | 
| Tumor recurrence or progression | Incidence of tumoral recurrence or progression | Two and five years of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiotoxicity, Elderly, Antineoplastic agents, Cardiovascular monitoring, Cardioprotection, Cardio-oncology, Chemically-Induced Disorders, Radiation Injuries, Drug-Related Side Effects and Adverse Reactions., Primary prevention, Secondary prevention., Mortality