Cardiovascular Complications of Carfilzomib (ICARE)

June 4, 2020 updated by: Mariana Mirabel, European Georges Pompidou Hospital

Insuffisance Cardiaque Sous Carfilzomib: étude Prospective

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Assistance Publique Hôpitaux de Paris - Centre Université de Paris
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective cohort of patients starting carfilzomib treatment.

Description

Inclusion Criteria:

  • Intention to treat by Carfilzomib

Exclusion Criteria:

  • History of carfilzomib treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardio-vasculo-toxicity of carfilzomib
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic hypertension
Time Frame: 6 months
Number of patients with as systemic hypertension
6 months
Heart Failure Reduced Ejection Fraction
Time Frame: 6 months
Number of patients with Heart Failure and Reduced Ejection Fraction
6 months
Heart Failure Preserved Ejection Fraction
Time Frame: 6 months
Number of patients with Heart Failure and Preserved Ejection Fraction
6 months
Predictors of Cardiotoxicity
Time Frame: 6 months
Correlation between cardio-vascular toxicity and patients' chacateristics.
6 months
Impact on outcomes
Time Frame: 1 year
Compare outcomes (mortality) in patients with cardiotoxicity and no cardiotoxicty.
1 year
Safety
Time Frame: 1 year
Compare outcomes (mortality) in patients with cardiotoxicity according to the continuation of carflzomib or its withdrawl.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Georges Pompidou Hospital

Investigators

  • Principal Investigator: Mariana Mirabel, Assistance Publique Hôpitaux de Paris - Université de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Anticipated)

May 21, 2021

Study Completion (Anticipated)

May 21, 2022

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00011928 ICARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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