Condition category
Circulatory System
Date applied
15/03/2007
Date assigned
29/03/2007
Last edited
17/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Azienda Ospedaliera Universitaria S.Martino (Italy)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Results in:
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=17591533

Publication citations

  1. 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.

Additional files

Editorial Notes