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RECRUITING
NCT03711110
NA

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

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

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

514

Start Date

2019-08-02

Completion Date

2025-11-30

Last Updated

2025-03-21

Healthy Volunteers

No

Interventions

OTHER

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 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.

OTHER

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

Locations (14)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Hospital de Galdakao-Usansolo

Galdakao, Vizcaya, Spain

Hospital Universitario Vall d´Hebron

Barcelona, Spain

Hospital Universitario Reina Sofía

Córdoba, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital G. Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Universitario Río Hortega

Valladolid, Spain