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

Novartis

Status: Completed

Conditions: Coronary Heart Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00134940

CRAD001A2424

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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/exclusion criteria may apply.