Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)CARTIERNCT03711110
Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)
A study testing Intensive cardiovascular monitoring in people with Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma) and Elderly, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 14 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Elderly, Antineoplastic Agents
- What is being tested?
- Intensive cardiovascular monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 14 sitesSpain
- Study dates
- 2 Aug 2019to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- > 65 years old
- Expected survival >1 year
- Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma
- Signature on the informed consent
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Spain14 sites, 14 recruiting
- Not yet recruiting
Hospital Universitario Vall d´Hebron
Barcelona, 08035
Ignacio Ferreira-González, MD, +34 91 336 80 00, nachoferreira@secardiologia.es
Ignacio Ferreira-González, MD
- Not yet recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
Dolores Mesa, MD, +34 957 010 000, loladoctora@gmail.com
Dolores Mesa, MD
- Not yet recruiting
Hospital de Galdakao-Usansolo
Galdakao, Vizcaya, 48960
Sonia Velasco, MD, +34 944 007 000, soniavelascodelcastillo@gmail.com
Sonia Velasco, MD
- Not yet recruiting
Hospital Universitario de La Princesa
Madrid, 28006
Fernando Alfonso-Manterola, +34 915 202 200, falf@hotmail.com
Fernando Alfonso-Manterola, Md
- Not yet recruiting
Hospital G. Universitario Gregorio Marañón
Madrid, 28009
Eduardo Zatarain-Nicolás, +34 915 868 000, eduzatanico@gmail.com
Eduardo Zatarain-Nicolás, MD
- Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Ana Pardo-Sanz, MD, +34 91 336 80 00, anapardosanz0@gmail.com
Ana Pardo-Sanz, MD
- Not yet recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Luis F Navarro-del-Amo, MD, +34 915 504 800, fnavarro@gmail.com
Luis F Navarro-del-Amo, MD
- Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Carmen Jiménez-López-Guarch, MD, +34 91 390 80 00, cjlguarch@gmail.com
Carmen Jiménez-López-Guarch, MD
- Not yet recruiting
Hospital Universitario Puerta de Hierro
Madrid, 28222
Cristina Mitroi, MD, +34 911 916 565, cristina_mitroi@hotmail.com
Cristina Mitroi, MD
- Not yet recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Juan J Gómez-Doblas, +34 951 032 000, jjgomezdoblas@gmail.com
Juan J Gómez-Doblas, MD
- Recruiting
Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Ana Martín-García, Ph. D., +34 923291100 ext. 55356, amartingarcia@usal.es
Ana Martín-García, Ph. D.
- Not yet recruiting
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Pilar Mazón-Ramos, MD, +34 981 950 000, pilarmazon@yahoo.es
Pilar Mazón-Ramos, MD
- Not yet recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Gonzalo Baron-Esquivias, +34 955 012 000, gonzalo.baron.sspa@juntadeandalucia.es
Gonzalo Baron-Esquivias, MD
- Not yet recruiting
Hospital Universitario Río Hortega
Valladolid, 47012
Marina Revilla-Martínez, MD, +34 983 420 400, marinarema@hotmail.com
Marina Revilla-Martínez, MD
About this study
Official title: Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies
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.
Read more
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
- Conditions
- Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Elderly, Antineoplastic Agents, Cardiotoxicity
- Being tested
- Intensive cardiovascular monitoring, No intervention
- 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
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Breast Neoplasms, Lymphoma, Multiple Myeloma, Cardiotoxicity, Chemically-Induced Disorders, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive cardiovascular monitoringOther
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 interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Primary prevention strategy | Experimental | Intensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care. Receives: Other: Intensive cardiovascular monitoring |
| Secondary prevention strategy (control) | Other | Current clinical practice: cardiac care is based on the onco-hematologist criteria. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Cumulative incidence of all-cause mortality
Measured: Two (mid-term analysis) and five years of follow-up
Secondary outcomes (6)
Oncological mortality
Cumulative incidence of oncological mortality
Measured: Two and five years of follow-up
Cardiovascular mortality
Cumulative incidence of cardiovascular mortality
Measured: Two and five years of follow-up
Hospitalization
Cumulative incidence of hospitalization
Measured: Two and five years of follow-up
Hospitalization/emergency cardiovascular cause
Cumulative incidence of hospitalization and/or emergency care for cardiovascular cause
Measured: Two and five years of follow-up
Hospitalization/emergency cancer cause
Cumulative incidence of hospitalization and/or emergency care for cancer cause
Measured: Two and five years of follow-up
Tumor recurrence or progression
Incidence of tumoral recurrence or progression
Measured: Two and five years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start2 Aug 2019
- Primary completion2 Aug 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies
- Masking
- None (open label)
- Enrolment
- 514 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Pedro L Sánchez, Ph. D., Study director, IBSAL-Instituto de Investigación Biomédica de SalamancaAna Martín-García, Ph. D., Study director, IBSAL-Instituto de Investigación Biomédica de Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711110
- Sponsor's protocol ID
- CARTIER
- Acronym
- CARTIER
- Status last verified
- Mar 2025
- First submitted
- 9 Oct 2018
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies
- ClinicalTrials.gov ID
- NCT03711110
- Acronym / sponsor ID
- CARTIER / CARTIER
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 514 participants (estimated)
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y LeónUniversity, hospital or other
- Collaborators
- Instituto de Investigación Biomédica de Salamanca, Instituto de Salud Carlos III
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies
| Arm | Type | Receives |
|---|---|---|
| Primary prevention strategy | Experimental | Other: Intensive cardiovascular monitoringIntensive cardiovascular monitoring focused on prevention and early diagnosis and treatment of cardiotoxicity based in cardio-onco-hematology teams involved in cancer patient care. |
| Secondary prevention strategy (control) | Other | Other: No interventionCurrent clinical practice: cardiac care is based on the onco-hematologist criteria. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- > 65 years old
- Expected survival >1 year
- Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma
- Signature on the informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive cardiovascular monitoringSchedule 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 | Primary prevention strategy |
| No interventionSchedule 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 | Other | Secondary prevention strategy (control) |
Primary outcome
All-cause mortality
Time frame: Two (mid-term analysis) and five years of follow-up
Cumulative incidence of all-cause mortality
6 secondary outcomes
Oncological mortality
Time frame: Two and five years of follow-up
Cardiovascular mortality
Time frame: Two and five years of follow-up
Hospitalization
Time frame: Two and five years of follow-up
Hospitalization/emergency cardiovascular cause
Time frame: Two and five years of follow-up
Hospitalization/emergency cancer cause
Time frame: Two and five years of follow-up
Tumor recurrence or progression
Time frame: Two and five years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro L Sánchez, Ph. D. study director
IBSAL-Instituto de Investigación Biomédica de Salamanca
Ana Martín-García, Ph. D. study director
IBSAL-Instituto de Investigación Biomédica de Salamanca
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive cardiovascular monitoring in people with Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma) and Elderly, run by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro L Sánchez, Ph. D. (923 291100 ext. 55356, plsanchez@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Two (mid-term analysis) and five years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.