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NCT04407858 Clinical Trial

Cardiovascular Complications of Carfilzomib

Hypertension Clinical Trial

— ICARE  

Official title:
Insuffisance Cardiaque Sous Carfilzomib: étude Prospective

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04407858
Other study ID # 00011928 ICARE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 21, 2020
Est. completion date May 21, 2022

Study information
Verified date June 2020
Source European Georges Pompidou Hospital
Contact Mariana Mirabel
Phone +33156095636
Email mariana.mirabel@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date May 21, 2022
Est. primary completion date May 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Intention to treat by Carfilzomib

Exclusion Criteria:

- History of carfilzomib treatment

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Assistance Publique Hôpitaux de Paris - Centre Université de Paris Paris

Sponsors (1)
Lead Sponsor Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of cardio-vasculo-toxicity of carfilzomib Number of patients with cardio-toxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of carfilzomib. 6 months
Secondary Systemic hypertension Number of patients with as systemic hypertension 6 months
Secondary Heart Failure Reduced Ejection Fraction Number of patients with Heart Failure and Reduced Ejection Fraction 6 months
Secondary Heart Failure Preserved Ejection Fraction Number of patients with Heart Failure and Preserved Ejection Fraction 6 months
Secondary Predictors of Cardiotoxicity Correlation between cardio-vascular toxicity and patients' chacateristics. 6 months
Secondary Impact on outcomes Compare outcomes (mortality) in patients with cardiotoxicity and no cardiotoxicty. 1 year
Secondary Safety Compare outcomes (mortality) in patients with cardiotoxicity according to the continuation of carflzomib or its withdrawl. 1 year
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