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NCT Number: NCT03711110

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

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive cardiovascular monitoring

Other

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

Other

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

Primary outcomes

  1. All-cause mortality

    Time frame: Two (mid-term analysis) and five years of follow-up

    Cumulative incidence of all-cause mortality

Secondary outcomes

  1. Oncological mortality

    Time frame: Two and five years of follow-up

    Cumulative incidence of oncological mortality

  2. Cardiovascular mortality

    Time frame: Two and five years of follow-up

    Cumulative incidence of cardiovascular mortality

  3. Hospitalization

    Time frame: Two and five years of follow-up

    Cumulative incidence of hospitalization

  4. Hospitalization/emergency cardiovascular cause

    Time frame: Two and five years of follow-up

    Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause

  5. Hospitalization/emergency cancer cause

    Time frame: Two and five years of follow-up

    Cumulative incidence of hospitalization and/or emergency care for cancer cause

  6. Tumor recurrence or progression

    Time frame: Two and five years of follow-up

    Incidence of tumoral recurrence or progression

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Martín-García, Ph. D.

CONTACT

[email protected]

923 291100 ext. 55356

Pedro L Sánchez, Ph. D.

CONTACT

[email protected]

923 291100 ext. 55356

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Instituto de Investigación Biomédica de Salamanca
  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: CARTIER

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Oct 18, 2018
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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