Hypertrophy, Left VentricularPhase 4ENHVIENCT03415750
Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants
A Phase 4 study testing Everolimus, Mycophenolate mofetil and Tacrolimus in people with Hypertrophy, Left Ventricular, run by Edoardo Melilli at 1 site in Spain.
Trial summary
Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophy, Left Ventricular
- What is being tested?
- Everolimus, Mycophenolate mofetil and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to May 2020
- 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
- Patient's signed informed consent prior to any study-related procedure.
- Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
- Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
- Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
- Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
- No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
- Patients with Hb levels ≥ 11 gr/dl.
- Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.
Who cannot join
- Patient's signed informed consent prior to any study-related procedure.
- Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
- Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
- Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
- Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
- No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
- Patients with Hb levels ≥ 11 gr/dl.
- Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: A Single-center,Randomized,Open-label,12 Months Study,2 Parallel Group to Compare the Efficacy of Everolimus Combination + Tacrolimus in Regression of Left Ventricular Hypertrophy vs Tacrolimus + MMF in Renal Transplant Patients
Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
Read the detailed description
A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
- Conditions
- Hypertrophy, Left Ventricular
- Being tested
- Everolimus, Mycophenolate mofetil, Tacrolimus
- Keywords
- Renal transplant
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
Conversion from Mycophenolate mofetil to Everolimus
Also called Cellcept
Patients will remain in Tacrolimus + Mycophenolate mofetil
TacrolimusDrug
Also called Prograf
| Study group | Role | What they receive |
|---|---|---|
| Everolimus arm | Experimental | Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus' Receives: Drug: Everolimus; Drug: Tacrolimus |
| Mycophenolate arm | Active comparator | Patients will remain in Tacrolimus + Mycophenolate mofetil combination Receives: Drug: Mycophenolate mofetil; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Left Ventricular Hypertrophy
Reduction of Left Ventricular Hypertrophy more or equal than 10 g/m2 in the study group compared to control group at 12 months. Regression of LVH is defined as a decrease of 10 g/m2 compared to baseline value. Cardio nuclear magnetic resonance will be performed to evaluate left ventricular hypertrophy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study startNov 2016
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophy, Left VentricularStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edoardo Melilli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edoardo Melilli, Hospital Universitari de Bellvitge
- Investigators
- Edoardo Melilli, MD, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415750
- Sponsor's protocol ID
- ENHVIE
- Acronym
- ENHVIE
- Status last verified
- Jan 2021
- First submitted
- 17 Nov 2016
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center,Randomized,Open-label,12 Months Study,2 Parallel Group to Compare the Efficacy of Everolimus Combination + Tacrolimus in Regression of Left Ventricular Hypertrophy vs Tacrolimus + MMF in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT03415750
- Acronym / sponsor ID
- ENHVIE / ENHVIE
- Conditions
- Hypertrophy, Left Ventricular
- Keywords
- Renal transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Edoardo MelilliUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 30 Jan 2018 (actual)
- 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.
Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
Detailed description
A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus arm | Experimental | Drug: Everolimus, Drug: TacrolimusPatients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus' |
| Mycophenolate arm | Active comparator | Drug: Mycophenolate mofetil, Drug: TacrolimusPatients will remain in Tacrolimus + Mycophenolate mofetil combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient's signed informed consent prior to any study-related procedure.
- Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
- Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
- Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
- Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
Key exclusion criteria (8 listed)
- Patient's signed informed consent prior to any study-related procedure.
- Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
- Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
- Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
- Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
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: CerticanConversion from Mycophenolate mofetil to Everolimus | Drug | Everolimus arm |
| Mycophenolate mofetilAlso: CellceptPatients will remain in Tacrolimus + Mycophenolate mofetil | Drug | Mycophenolate arm |
| TacrolimusAlso: Prograf | Drug | Everolimus arm, Mycophenolate arm |
Primary outcome
Reduction of Left Ventricular Hypertrophy
Time frame: 12 months
Reduction of Left Ventricular Hypertrophy more or equal than 10 g/m2 in the study group compared to control group at 12 months. Regression of LVH is defined as a decrease of 10 g/m2 compared to baseline value. Cardio nuclear magnetic resonance will be performed to evaluate left ventricular hypertrophy
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 8 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Hypertrophy, Left Ventricular
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Therapeutic Implications of CMR Low Native T1 in Non-treated Non-hypertrophic Females With Fabry Disease (FD)
Fabry Disease
RecruitingPhase 2
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
Danon Disease
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.
Edoardo Melilli, MD principal investigator
Hospital Universitari de Bellvitge
1 site 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, Mycophenolate mofetil and Tacrolimus in people with Hypertrophy, Left Ventricular, run by Edoardo Melilli at 1 site 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 8 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: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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.
What does the primary outcome measure?
Reduction of Left Ventricular Hypertrophy (time frame: 12 months). 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 8 Jan 2021.