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

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Status: Enrolling

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

Treatments: Other: No intervention; Other: Intensive cardiovascular monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03711110

CARTIER

Details and patient eligibility

About

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

Enrollment: 514 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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514 participants in 2 patient groups

Primary prevention strategy

Experimental group

Description:

Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care.

Treatment:

Other: Intensive cardiovascular monitoring

Secondary prevention strategy (control)

Other group

Description:

Current clinical practice: cardiac care is based on the onco-hematologist criteria.

Treatment:

Other: No intervention