NCT00134940

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

August 23, 2005

Last Update Submit

June 15, 2011

Conditions

Coronary Heart Disease

Keywords

Transplantation, heartOrgan transplant

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

  • Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novarits

Graz, Austria

Location

Novartis Investigative Site

Innsbruck, Austria

Location

Novartis

Wein, Austria

Location

Novartis

Bad Oeynhausen, Germany

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis

Erlangen, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

January 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

AU(3)DE(3)