Condition category
Urological and Genital Diseases
Date applied
16/01/2010
Date assigned
18/02/2010
Last edited
18/02/2010
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 Giacomo Deferrari

ORCID ID

Contact details

Rettorato Università di Genova
Via Balbi 5
Genova
16100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Chronic kidney disease and cardiovascular risk in primary care

Acronym

GENOA

Study hypothesis

To analyse the influence of estimated glomerular filtration rate and proteinuria on survival, free of cardiovascular and renal events, and to test the accuracy of calculators including renal function indices in predicting cardiovascular outcomes of primary care patients

Ethics approval

Trial not requiring ethical approval as study design is completely adherent to the recommendations issued by the local ethical committee of Azienda Ospedaliera S. Martino (Genova, Italy) and in accordance to the guidelines issued by the Helsinki declaration.

Study design

Retrospective analysis and observational prospective study

Primary study design

Observational

Secondary study design

Other

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please contact noberasco@ebinobisas.191.it to request a patient information sheet.

Condition

Chronic kidney disease

Intervention

Data will be extracted from the Health Search Database (HSD). The HSD was set up in 1998 and managed by the Italian College of GPs. The HSD contains information provided by more than 650 Italian GPs, and includes data on more than 1,000,000 individuals.
Demographic, clinical and laboratory data, namely age, sex, body weight, height, blood pressure (BP) values, serum lipids, and serum creatinine will be evaluated for each patient. The presence of diabetes, smoking habits, and the occurrence of previous major cardiovascular events, such as stroke, angina and myocardial infarction will also be extracted from the HSD for each patient. The number and classes of antihypertensive medications will also be retrieved for each patient. Global cardiovascular risk will be calculated for each subject by various calculators including the Framingham, the Heart Score, and the INDANA. Follow-up will be about 5-7 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Death (any cause)

Secondary outcome measures

1. Survival free of cardiovascular events
2. Survival free of renal event
3. Accuracy of different risk calculators in predicting outcome

Overall trial start date

01/01/2003

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Italian general population followed in primary care

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70,000

Participant exclusion criteria

Subjects in whom serum creatinine measurement is not available

Recruitment start date

01/01/2003

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Italy

Trial participating centre

Rettorato Università di Genova
Genova
16100
Italy

Sponsor information

Organisation

Carige Foundation (Fondazione Carige [Cassa di Risparmio di Genova e Imperia]) (Italy)

Sponsor details

Via G. D'Annunzio 15
16100
Genova
Genova
16100
Italy

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Carige Foundation (Fondazione Carige [Cassa di Risparmio di Genova e Imperia]) (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

Publication citations

Additional files

Editorial Notes