Angiotensin Converting Enzyme (ACE) inhibitors in renal transplant recipients with left ventricular hypertrophy
| ISRCTN | ISRCTN94487168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94487168 |
| Protocol serial number | N/A |
| Sponsor | Azienda Ospedaliera Universitaria S.Martino (Italy) |
| Funders | The Italian National Health Service (SSN, Servizio Sanitario Nazionale) (Italy), Azienda Ospedaliera Universitaria S.Martino (Italy) |
- Submission date
- 15/03/2007
- Registration date
- 29/03/2007
- Last edited
- 28/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Giuseppe Cannella
Scientific
Scientific
Divisione di Nefrologia, Dialisi e Trapianto
Azienda Ospedaliera Universitaria S.Martino
Genova
16132
Italy
| giuseppe.cannella@hsanmartino.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label randomized trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Angiotensin Converting Enzyme (ACE) inhibitors in renal transplant recipients with left ventricular hypertrophy |
| Study objectives | To test the effect of ACE inhibitors as compared to no therapy in regressing the left ventricular hypertrophy (LVH) that persisted longer following renal transplantation |
| Ethics approval(s) | This trial did not require an ethical approval as the trial design was completely adherent to the recommendations issued by the local ethical committee Azienda Ospedaliera S. Martino (Genova, Italy) and in accordance to the guidelines issued by the Helsinki declaration. |
| Health condition(s) or problem(s) studied | Left ventricular hypertrophy assessed by echocardiography in non diabetic chronic kidney disease patients receiving renal transplant |
| Intervention | Randomization to either ACE inhibitors or no therapy. Conventional antihypertensive therapy allowed in order to achieve blood pressure (BP) nearly 130/80 mmHg |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | ACE inhibitors |
| Primary outcome measure(s) |
Change in left ventricularvmass index at 18 months |
| Key secondary outcome measure(s) |
Cardiovascular events during follow-up |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 70 |
| Total final enrolment | 70 |
| Key inclusion criteria | Non diabetic renal transplant recipients with persisting LVH following successful renal transplant |
| Key exclusion criteria | 1. Subjects receiving second or dual transplant 2. Subjects with unstable renal graft function 3. Proteinuria > 1 g/ 24 hr 4. Congestive heart failure 5. Hemodinamically significant artery stenosis |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Italy
Study participating centre
Divisione di Nefrologia, Dialisi e Trapianto
Genova
16132
Italy
16132
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2007 | Yes | No |
Editorial Notes
28/10/2022: Total final enrolment added.
