Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus

A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00134940

Enrollment

100

Registered

2005-08-25

Start date

2005-01-31

Completion date

2006-11-30

Last updated

2011-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Transplantation, heart, Organ transplant

Brief summary

The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants. Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Cardiac transplant recipients * Discharged alive from hospital * Must be receiving everolimus

Exclusion criteria

* Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant Other inclusion/

Countries

Austria, Germany

Outcome results