Status:
COMPLETED
Pharmacosurveillance and Pharmacogenetics of First-line Diuretics in Hypertension: The StayOnDiur Study
Lead Sponsor:
Federico II University
Collaborating Sponsors:
Agenzia Italiana del Farmaco
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Background: The use of thiazide diuretics in the treatment of hypertension (HT) is widely considered a first line treatment, given the efficacy and low cost of this class of drugs. This indication is ...
Detailed Description
Background and rationale Many comments have been issued about similarities and differences between 2003 American and European guidelines for the management of arterial hypertension (1,2), especially ...
Eligibility Criteria
Inclusion
- Hypertensive patients will be 18 to 75-year old.
- Eligible patients will be asked for written informed consent and thereafter referred to the identified Hypertension Specialist Centre located in their areas, for end-organ damage evaluation by echocardiography, carotid ultrasound and urine dip-stick.
- Eligible patients are required to have stage Ic or II essential hypertension, and to be previously untreated or poorly controlled. They will be selected by GPs participating into the study. Similar to untreated patients, those with poor control of blood pressure under multiple-drug therapy will start treatment with one single drug, which will be titrated to the highest dose before adding subsequent medications, based on the GP's judgement.
- Hypertension will be defined according to 2003 ESH/ESC guidelines (1). Blood and urine tests will be performed, according to guidelines for Hypertension Management For General Practitioners (GP) of the Regione Campania (see BURC number 11, 18/02/2002). This screening includes cell blood counts (CBCs), serum creatinine, sodium, potassium, uric acid, total cholesterol, triglycerides, HDL-cholesterol, glucose, urine analysis and EKG. LDL will be calculated starting from the total cholesterol, triglyceride and HDL-cholesterol.
Exclusion
- Omen in fertile age not using recognized contraceptive methods, or pregnant or nursing will be excluded from the protocol, since the use of many antihypertensive drugs is contraindicated in pregnancy and lactation.
- Patients will be excluded when presenting with documented coronary or cerebrovascular events in the previous 6 months, NYHA class higher than 1
- History of congestive heart failure
- Secondary hypertension
- Cancer disease
- Renal disease (serum creatinine \>2 mg/dl)
- Liver cirrhosis or severe dysfunction, or any other health problem that may interfere with the projected 2 year follow-up.
- Data will be stored in an electronic database located in the Coordinating Centre, to which GPs may have access for uploading data on a daily base, using personal, encrypted, login and password. These data will be stored in the central database. After local echocardiographic evaluation, patients showing left ventricular Ejection Fraction \< 45% will be excluded from the study.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00408512
Start Date
December 1 2006
End Date
March 1 2010
Last Update
June 27 2011
Active Locations (1)
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1
Ambulatorio Ipertensione e Unità Coronarica Federico II University
Napoli, Italy, 80131