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

Elderly Clinical Trial

— CARTIER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711110
• Other study ID #: CARTIER
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Contact: Pedro L Sánchez, Ph. D.
• Phone: 923 291100
• Email: plsanchez[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 514
• Est. completion date: November 30, 2025
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antineoplastic Agents
• Breast Neoplasms
• Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)
• Cardiotoxicity
• Elderly
• Multiple Myeloma

Intervention

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.
• 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

Country	Name	City	State
Spain	Hospital Universitario Vall d´Hebron	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital de Galdakao-Usansolo	Galdakao	Vizcaya
Spain	Hospital G. Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago De Compostela	A Coruña
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Río Hortega	Valladolid

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León	Instituto de Investigación Biomédica de Salamanca, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Cumulative incidence of all-cause mortality	Two (mid-term analysis) and five years of follow-up
Secondary	Oncological mortality	Cumulative incidence of oncological mortality	Two and five years of follow-up
Secondary	Cardiovascular mortality	Cumulative incidence of cardiovascular mortality	Two and five years of follow-up
Secondary	Hospitalization	Cumulative incidence of hospitalization	Two and five years of follow-up
Secondary	Hospitalization/emergency cardiovascular cause	Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause	Two and five years of follow-up
Secondary	Hospitalization/emergency cancer cause	Cumulative incidence of hospitalization and/or emergency care for cancer cause	Two and five years of follow-up
Secondary	Tumor recurrence or progression	Incidence of tumoral recurrence or progression	Two and five years of follow-up