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
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

Not provided at time of registration

Contact information

Prof Giuseppe Cannella
Scientific

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

giuseppe.cannella@hsanmartino.it

Study information

Study designOpen-label randomized trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific titleAngiotensin Converting Enzyme (ACE) inhibitors in renal transplant recipients with left ventricular hypertrophy
Study hypothesisTo 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.
ConditionLeft ventricular hypertrophy assessed by echocardiography in non diabetic chronic kidney disease patients receiving renal transplant
InterventionRandomization to either ACE inhibitors or no therapy.
Conventional antihypertensive therapy allowed in order to achieve blood pressure (BP) nearly 130/80 mmHg
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)ACE inhibitors
Primary outcome measureChange in left ventricularvmass index at 18 months
Secondary outcome measuresCardiovascular events during follow-up
Overall study start date01/01/2001
Overall study end date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants70
Total final enrolment70
Participant inclusion criteriaNon diabetic renal transplant recipients with persisting LVH following successful renal transplant
Participant exclusion criteria1. 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 date01/01/2001
Recruitment end date31/12/2005

Locations

Countries of recruitment

  • Italy

Study participating centre

Divisione di Nefrologia, Dialisi e Trapianto
Genova
16132
Italy

Sponsor information

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

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

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

Funders

Funder type

Government

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

No information available

Azienda Ospedaliera Universitaria S.Martino (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.

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