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

Who is this study for? Patients with Cancer
What treatments are being studied? Intensive Cardiovascular Monitoring
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• \> 65 years old

• Expected survival \>1 year

• Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma

• Signature on the informed consent

Locations
Other Locations
Spain
Hospital Universitario Vall d´Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Reina Sofía
NOT_YET_RECRUITING
Córdoba
Hospital de Galdakao-Usansolo
NOT_YET_RECRUITING
Galdakao
Hospital G. Universitario Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario de La Princesa
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
NOT_YET_RECRUITING
Málaga
Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Clínico Universitario de Santiago de Compostela
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Hospital Universitario Río Hortega
NOT_YET_RECRUITING
Valladolid
Contact Information
Primary
Pedro L Sánchez, Ph. D.
plsanchez@saludcastillayleon.es
923 291100
Backup
Ana Martín-García, Ph. D.
amartingarcia@usal.es
923 291100
Time Frame
Start Date: 2019-08-02
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 514
Treatments
Experimental: Primary prevention strategy
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: Secondary prevention strategy (control)
Current clinical practice: cardiac care is based on the onco-hematologist criteria.
Sponsors
Collaborators: Instituto de Investigación Biomédica de Salamanca, Instituto de Salud Carlos III
Leads: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

This content was sourced from clinicaltrials.gov