GEneral Practitioners and Nephrologists for Outpatient Assistance

ISRCTN	ISRCTN09810203
DOI	https://doi.org/10.1186/ISRCTN09810203
Secondary identifying numbers	N/A

Submission date: 16/01/2010
Registration date: 18/02/2010
Last edited: 18/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Giacomo Deferrari
Scientific

Rettorato Università di Genova
Via Balbi 5
Genova
16100
Italy

Study information

Study design	Retrospective analysis and observational prospective study
Primary study design	Observational
Secondary study design	Other
Study setting(s)	GP practice
Study type	Other
Participant information sheet	Not available in web format, please contact noberasco@ebinobisas.191.it to request a patient information sheet.
Scientific title	Chronic kidney disease and cardiovascular risk in primary care
Study acronym	GENOA
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2003
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	70,000
Key inclusion criteria	Italian general population followed in primary care
Key exclusion criteria	Subjects in whom serum creatinine measurement is not available
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Italy

Study participating centre

Rettorato Università di Genova

Genova
16100
Italy

Sponsor information

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

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

"ROR"	https://ror.org/03c79xe68

Funders

Funder type

Charity

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

No information available

Results and Publications

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