Angiotensin Converting Enzyme (ACE) inhibitors in renal transplant recipients with left ventricular hypertrophy

ISRCTN	ISRCTN94487168
DOI	https://doi.org/10.1186/ISRCTN94487168
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Giuseppe Cannella
Scientific

Divisione di Nefrologia, Dialisi e Trapianto
Azienda Ospedaliera Universitaria S.Martino
Genova
16132
Italy

Email	giuseppe.cannella@hsanmartino.it

Study design	Open-label randomized trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	ACE inhibitors
Primary outcome measure	Change in left ventricularvmass index at 18 months
Secondary outcome measures	Cardiovascular events during follow-up
Overall study start date	01/01/2001
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Divisione di Nefrologia, Dialisi e Trapianto

Genova
16132
Italy

Azienda Ospedaliera Universitaria S.Martino (Italy)
University/education

c/o Prof Giuseppe Cannella
L.go R.Benzi 10
Genova
16132
Italy

"ROR"	https://ror.org/04d7es448

Government

The Italian National Health Service (SSN, Servizio Sanitario Nazionale) (Italy)

No information available

Azienda Ospedaliera Universitaria S.Martino (Italy)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/07/2007		Yes	No

28/10/2022: Total final enrolment added.