Clinical trial NCT03711110: Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)
Official title: Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
Elderly
Antineoplastic Agents
Cardiotoxicity
Keywords: 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
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
name: Instituto de Salud Carlos III
First posted: 2018-10-18
Enrollment: 514
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: Two (mid-term analysis) and five years of follow-up
Secondary outcomes:
measure: Oncological mortality
timeFrame: Two and five years of follow-up
measure: Cardiovascular mortality
timeFrame: Two and five years of follow-up
measure: Hospitalization
timeFrame: Two and five years of follow-up
measure: Hospitalization/emergency cardiovascular cause
timeFrame: Two and five years of follow-up
measure: Hospitalization/emergency cancer cause
timeFrame: Two and five years of follow-up
measure: Tumor recurrence or progression
timeFrame: Two and five years of follow-up
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
state: A Coruña
city: Galdakao
country: Spain
facility: Hospital de Galdakao-Usansolo
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d´Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital G. Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Salamanca
country: Spain
facility: Complejo Asistencial Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
Study officials:
affiliation: IBSAL-Instituto de Investigación Biomédica de Salamanca
name: Pedro L Sánchez, Ph. D.
role: STUDY_DIRECTOR
affiliation: IBSAL-Instituto de Investigación Biomédica de Salamanca
name: Ana Martín-García, Ph. D.
role: STUDY_DIRECTOR
References: