Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

Cardiovascular Complication Clinical Trial

— NEOCARDIO  

Official title:

Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03882580
• Other study ID #: CIC1421-19-05
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: March 1, 2025

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: Joe-Elie Salem, MD, PhD
• Phone: (0)1 42 17 85 33
• Email: joe-elie.salem[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).

Description:

Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suffering a cancer

• Evaluated within a cardio-oncology program

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiac Complication
• Cardiac Disorder
• Cardiac Insufficiency
• Cardiotoxicity
• Cardiovascular Complication
• Cardiovascular Insufficiency
• Disease
• Heart Diseases
• Heart Failure
• Metabolic Diseases
• Metabolic Disorder
• Oncologic Complications
• Vascular Diseases
• Vascular Disorder

Intervention

Drug:
• Anti-Cancer Agents
Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris
France	AP-HP, Saint-Antoine Hospital, Department of cardiology	Paris
France	AP-HP, Tenon Hospital, Department of Cardiology	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

References & Publications (1)

Salem JE, Allenbach Y, Vozy A, Brechot N, Johnson DB, Moslehi JJ, Kerneis M. Abatacept for Severe Immune Checkpoint Inhibitor-Associated Myocarditis. N Engl J Med. 2019 Jun 13;380(24):2377-2379. doi: 10.1056/NEJMc1901677. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients having a benefit after this specific cardio-oncology check up and follow up		5 years
Secondary	Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments		5 years
Secondary	All relevants staisticals associations between adverse events and anticancer drugs		5 years
Secondary	All relevant statistical associations between cardiovascular toxicities, and anticancer drugs		5 years
Secondary	All relevants statistical associations between cardiovascular side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments		5 years
Secondary	All relevant statistical associations between duration and type of treatement used to manage cardiovascular side effects induced by oncology treatments, and overall survival		5 years
Secondary	All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments		5 years
Secondary	All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival		5 years
Secondary	All relevant statistical associations between the pre therapeutic cardiovascular checkup and follow up for patients with cancer or history of cancer, and the occurence of cardiovascular toxicities of oncology treatments.		5 years
Secondary	All relevant statistical associations between metabolic toxicities, and anticancer drugs		5 years
Secondary	All relevants statistical associations between metabolic side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments		5 years
Secondary	All relevant statistical associations between duration and type of treatement used to manage metabolic side effects induced by oncology treatments, and overall survival		5 years
Secondary	All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments		5 years
Secondary	All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival		5 years
Secondary	All relevant statistical associations between the pre therapeutic metabolic checkup and follow up for patients with cancer or history of cancer, and the occurence of metabolic toxicities of oncology treatments.		5 years