Coronary Heart DiseaseNCT00134940
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
An observational study of Coronary Heart Disease, run by Novartis at 6 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 100 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2005to Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Cardiac transplant recipients
- Discharged alive from hospital
- Must be receiving everolimus
Who cannot join
- Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant
- Other inclusion/exclusion criteria may apply.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Austria3 sites
Novarits
Graz
Novartis Investigative Site
Innsbruck
Novartis
Wein
Germany3 sites
Novartis
Bad Oeynhausen
Novartis Investigative Site
Berlin
Novartis
Erlangen
About this study
Official title: A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation
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
- Conditions
- Coronary Heart Disease
- Keywords
- Transplantation, heart, Organ transplant
- Medical subject headings
- Coronary Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134940
- Sponsor's protocol ID
- CRAD001A2424
- Status last verified
- Jun 2011
- First submitted
- 23 Aug 2005
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT00134940
- Acronym / sponsor ID
- CRAD001A2424
- Conditions
- Coronary Heart Disease
- Keywords
- Transplantation, heart, Organ transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- Cardiac transplant recipients
- Discharged alive from hospital
- Must be receiving everolimus
Key exclusion criteria (2 listed)
- Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant
- Other inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Novartis at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.