Contact information
Type
Scientific
Primary contact
Prof Giuseppe Cannella
ORCID ID
Contact details
Divisione di Nefrologia
Dialisi e Trapianto
Azienda Ospedaliera Universitaria S.Martino
Genova
16132
Italy
giuseppe.cannella@hsanmartino.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
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.
Study design
Open-label randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
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 names
ACE inhibitors
Primary outcome measure
Change in left ventricularvmass index at 18 months
Secondary outcome measures
Cardiovascular events during follow-up
Overall trial start date
01/01/2001
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Non diabetic renal transplant recipients with persisting LVH following successful renal transplant
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
70
Participant 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
Recruitment start date
01/01/2001
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Divisione di Nefrologia, Dialisi e Trapianto
Genova
16132
Italy
Funders
Funder type
Government
Funder name
The Italian National Health Service (SSN, Servizio Sanitario Nazionale) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Azienda Ospedaliera Universitaria S.Martino (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in:
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=17591533
Publication citations
-
Results
Paoletti E, Cassottana P, Amidone M, Gherzi M, Rolla D, Cannella G, ACE inhibitors and persistent left ventricular hypertrophy after renal transplantation: a randomized clinical trial., Am. J. Kidney Dis., 2007, 50, 1, 133-142, doi: 10.1053/j.ajkd.2007.04.013.