Cardiac TransplantPhase 4EVEROSTATNCT00695344
Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant
A Phase 4 study testing everolimus and azathioprine or mycophenolate mofetil in people with Cardiac Transplant, run by Fundacion Investigacion y Desarrollo at 8 sites in Spain.
Trial summary
The purpose of this study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes Everolimus, compared to those that continue the previously used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Transplant
- What is being tested?
- everolimus and azathioprine or mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 8 sitesSpain
- Study dates
- Jan 2006to Jun 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering a heart transplantation at least 12 months before the inclusion.
- Patients with significant graft vascular cardiac illness.
Who cannot join
- Patients who received more than one solid organ.
- Hypersensibility to everolimus.
- Patients with expected surviving less than 6 months.
- Analytic abnormality significant (platelets < 70.000 plat./mm3, WBC<4.000./mm3, creatinine > 2,5 mg/dl)
- Neoplasm and/or severe systemic illness.
- Mental significant illness.
- Patients who have received sirolimus or everolimus in any moment after transplant.
- Pregnant or lactating woman.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Hospital de Bellvitge
Barcelona, Barcelona, 08907
Hospital Gregorio Marañón
Madrid, Madrid, 28007
Hospital Puerta de Hierro
Madrid, Madrid, 28035
Hospital 12 de Octubre
Madrid, Madrid, 28041
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
About this study
Official title: Prospective and Randomized Study to Evaluate the Effect of Everolimus in the Clinical and Intra-Cardiac Ecography Progression of Heart Graft Vascular Illness.
The purpose of this study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes Everolimus, compared to those that continue the previously used immunosuppressive treatment.
Read the detailed description
This is a prospective, randomized, multicentre, open and controlled study, to evaluate the efficacy and safety of everolimus combined with cyclosporin for microemulsion and steroids according to medical judgement, opposite to the usual therapy which the patient already has received (typically: ciclosporin + azathioprine or mycophenolate mofetil + steroids according to the judgement of the doctor) for patients receiving a cardiac orthotopic transplant since at least 12 months. The patients will be randomized in a 2:1 proportion (everolimus:control), in order to make it possible for the majority of patients to receive the potentially active treatment in a lethal illness for which there is not efficient known treatment up to date.
The study duration will be 2 years of follow-up for each patient. At the end of this period, the patients will be offered the possibility to maintain the immunosuppressive treatment to which they have been assigned, and periodic revisions will be made each 3-6 months.
The two treatment groups are:
Group I - Everolimus twice a day v.o. + cyclosporin for microemulsion in reduced doses +/- steroids.
Group II - Cyclosporin for microemulsion + azathioprine or mycophenolate mofetil +/- steroids (the same administration schedule and medication which the patient received earlier).
- Conditions
- Cardiac Transplant
- Being tested
- everolimus, azathioprine or mycophenolate mofetil
- Keywords
- Effect of everolimus in graft vascular cardiac illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
Also called Certican
Everolimus 2 times per day, v.o., 2 years treatment.
azathioprine or mycophenolate mofetilDrug
Also called Imurel, Cellcept
2 times per day during 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Everolimus 2 times per day + cyclosporin low dose +/- steroids Receives: Drug: everolimus |
| 2 | Active comparator | Cyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study). Receives: Drug: azathioprine or mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects that present at least one major clinical event due to graft vascular illness during the first year of the study on both treatment arms.
Measured: December 2010
Secondary outcomes (1)
Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis.
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac TransplantStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Investigacion y Desarrollo
- Sponsor type
- University, hospital or other
- Investigators
- Javier Segovia, cardiologist, Principal investigator, Hospital Puerta de HierroNicolás Manito, Cardiologist, Principal investigator, Hospital Universitari de BellvitgeGregorio Rábago, Cardiologist, Principal investigator, Clínica Universitaria de NavarraFrancisco González-Vílchez, Cardiologist, Principal investigator, Hospital Marqués de ValdecillaJuan Delgado, Cardiologist, Principal investigator, Hospital 12 de OctubreJuan Fernández Yañez, Cardiologist, Principal investigator, Gregorio Marañón HospitalSonia Mirabet, Cardiologist, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauEulalia Roig, Cardiologist, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695344
- Sponsor's protocol ID
- EVEROSTAT
- Acronym
- EVEROSTAT
- Status last verified
- Jan 2009
- First submitted
- 9 Jun 2008
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Study to Evaluate the Effect of Everolimus in the Clinical and Intra-Cardiac Ecography Progression of Heart Graft Vascular Illness.
- ClinicalTrials.gov ID
- NCT00695344
- Acronym / sponsor ID
- EVEROSTAT / EVEROSTAT
- Conditions
- Cardiac Transplant
- Keywords
- Effect of everolimus in graft vascular cardiac illness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fundacion Investigacion y DesarrolloUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 11 Jun 2008 (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 study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes Everolimus, compared to those that continue the previously used immunosuppressive treatment.
Detailed description
This is a prospective, randomized, multicentre, open and controlled study, to evaluate the efficacy and safety of everolimus combined with cyclosporin for microemulsion and steroids according to medical judgement, opposite to the usual therapy which the patient already has received (typically: ciclosporin + azathioprine or mycophenolate mofetil + steroids according to the judgement of the doctor) for patients receiving a cardiac orthotopic transplant since at least 12 months. The patients will be randomized in a 2:1 proportion (everolimus:control), in order to make it possible for the majority of patients to receive the potentially active treatment in a lethal illness for which there is not efficient known treatment up to date.
The study duration will be 2 years of follow-up for each patient. At the end of this period, the patients will be offered the possibility to maintain the immunosuppressive treatment to which they have been assigned, and periodic revisions will be made each 3-6 months.
The two treatment groups are:
Group I - Everolimus twice a day v.o. + cyclosporin for microemulsion in reduced doses +/- steroids.
Group II - Cyclosporin for microemulsion + azathioprine or mycophenolate mofetil +/- steroids (the same administration schedule and medication which the patient received earlier).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: everolimusEverolimus 2 times per day + cyclosporin low dose +/- steroids |
| 2 | Active comparator | Drug: azathioprine or mycophenolate mofetilCyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffering a heart transplantation at least 12 months before the inclusion.
- Patients with significant graft vascular cardiac illness.
Key exclusion criteria (8 listed)
- Patients who received more than one solid organ.
- Hypersensibility to everolimus.
- Patients with expected surviving less than 6 months.
- Analytic abnormality significant (platelets < 70.000 plat./mm3, WBC<4.000./mm3, creatinine > 2,5 mg/dl)
- Neoplasm and/or severe systemic illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everolimusAlso: CerticanEverolimus 2 times per day, v.o., 2 years treatment. | Drug | 1 |
| azathioprine or mycophenolate mofetilAlso: Imurel, Cellcept2 times per day during 2 years | Drug | 2 |
Primary outcome
Percentage of subjects that present at least one major clinical event due to graft vascular illness during the first year of the study on both treatment arms.
Time frame: December 2010
1 secondary outcome
Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis.
Time frame: December 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
Related trials for Cardiac Transplant
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
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.
Javier Segovia, cardiologist principal investigator
Hospital Puerta de Hierro
Nicolás Manito, Cardiologist principal investigator
Hospital Universitari de Bellvitge
Gregorio Rábago, Cardiologist principal investigator
Clínica Universitaria de Navarra
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing everolimus and azathioprine or mycophenolate mofetil in people with Cardiac Transplant, run by Fundacion Investigacion y Desarrollo at 8 sites in Spain.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
What does the primary outcome measure?
Percentage of subjects that present at least one major clinical event due to graft vascular illness during the first year of the study on both treatment arms. (time frame: December 2010). It is what the study was designed to measure, not a finding.
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 30 Jan 2009.