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

NCT03711110 | Recruiting DMC

• 1 other identifier: CARTIER
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 14

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

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

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Cumulative incidence of all-cause mortality

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

Secondary Outcomes (6)

• Oncological mortality

  Two and five years of follow-up

• Cardiovascular mortality

  Two and five years of follow-up

• Hospitalization

  Two and five years of follow-up

• Hospitalization/emergency cardiovascular cause

  Two and five years of follow-up

• Hospitalization/emergency cancer cause

  Two and five years of follow-up

Study Arms (2)

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.

Other: Intensive cardiovascular monitoring

Secondary prevention strategy (control)

OTHER

Current clinical practice: cardiac care is based on the onco-hematologist criteria.

Other: No intervention

Interventions

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.

Primary prevention strategy

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

Secondary prevention strategy (control)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \> 65 years old
• Expected survival \>1 year
• Colon cancer, breast cancer, lymphoma, chronic lymphoma leukemia, chronic myeloid leukemia, myeloma
• Signature on the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator
• Instituto de Salud Carlos III: collaborator

Study Sites (14)

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, 15706, Spain

NOT YET RECRUITING

Hospital de Galdakao-Usansolo

Galdakao, Vizcaya, 48960, Spain

NOT YET RECRUITING

Hospital Universitario Vall d´Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

NOT YET RECRUITING

Hospital Universitario de La Princesa

Madrid, 28006, Spain

NOT YET RECRUITING

Hospital G. Universitario Gregorio Marañón

Madrid, 28009, Spain

NOT YET RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

NOT YET RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

NOT YET RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

NOT YET RECRUITING

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

NOT YET RECRUITING

Hospital Universitario Río Hortega

Valladolid, 47012, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Breast Neoplasms; Lymphoma; Multiple Myeloma; Cardiotoxicity; Chemically-Induced Disorders; Radiation Injuries; Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Pedro L Sánchez, Ph. D.

  IBSAL-Instituto de Investigación Biomédica de Salamanca

  STUDY DIRECTOR

• Ana Martín-García, Ph. D.

  IBSAL-Instituto de Investigación Biomédica de Salamanca

  STUDY DIRECTOR

Central Study Contacts

Pedro L Sánchez, Ph. D.

CONTACT

923 291100; plsanchez@saludcastillayleon.es

Ana Martín-García, Ph. D.

CONTACT

923 291100; amartingarcia@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, multicenter, open-label clinical trial comparing, in elderly patient with cancer under anti-tumoral treatment, two different cardiotoxicity prevention strategies

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 18, 2018
• Study Start: August 2, 2019
• Primary Completion: August 2, 2024
• Study Completion: November 30, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

ES (14)