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

Официальное название

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

Обзор

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

Вмешательства

• Другое Intensive cardiovascular monitoring
  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
• Другое No intervention
  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

Первичные конечные точки

• All-cause mortality [Срок оценки: Two (mid-term analysis) and five years of follow-up]

Вторичные конечные точки (6)

• Oncological mortality [Срок оценки: Two and five years of follow-up]
• Cardiovascular mortality [Срок оценки: Two and five years of follow-up]
• Hospitalization [Срок оценки: Two and five years of follow-up]
• Hospitalization/emergency cardiovascular cause [Срок оценки: Two and five years of follow-up]
• Hospitalization/emergency cancer cause [Срок оценки: Two and five years of follow-up]
• Tumor recurrence or progression [Срок оценки: Two and five years of follow-up]

Критерии участия

Критерии включения

• > 65 years old
• Expected survival >1 year
• Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma
• Signature on the informed consent

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Испания · 14 центров

• Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela
• Hospital de Galdakao-Usansolo — Galdakao
• Hospital Universitario Vall d´Hebron — Barcelona
• Hospital Universitario Reina Sofía — Córdoba
• Hospital Universitario de La Princesa — Madrid
• Hospital G. Universitario Gregorio Marañón — Madrid
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario Fundación Jiménez Díaz — Madrid
• … и ещё 6 центров

Идентификаторы

NCT: NCT03711110 · CARTIER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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