Heart Failure, Hypertension, Myeloma
Conditions
Keywords
Adverse drug event
Brief 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.
Interventions
None listed
Sponsors
European Georges Pompidou Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intention to treat by Carfilzomib
Exclusion criteria
* History of carfilzomib treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardio-vasculo-toxicity of carfilzomib | 6 months | Number of patients with cardio-toxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of carfilzomib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic hypertension | 6 months | Number of patients with as systemic hypertension |
| Heart Failure Reduced Ejection Fraction | 6 months | Number of patients with Heart Failure and Reduced Ejection Fraction |
| Heart Failure Preserved Ejection Fraction | 6 months | Number of patients with Heart Failure and Preserved Ejection Fraction |
| Predictors of Cardiotoxicity | 6 months | Correlation between cardio-vascular toxicity and patients' chacateristics. |
| Impact on outcomes | 1 year | Compare outcomes (mortality) in patients with cardiotoxicity and no cardiotoxicty. |
| Safety | 1 year | Compare outcomes (mortality) in patients with cardiotoxicity according to the continuation of carflzomib or its withdrawl. |
Countries
France
Contacts
Primary ContactMariana Mirabel
Outcome results
None listed