This is a pharmacogenomic prospective , four-arms, parallel groups, active comparator controlled study in essential hypertensive patients never treated before. Each patient will be genotyped for SNPs (single nucleotide polymorphism) in preliminary genetic profiles and will be treated according to their genetic profile with Peri (Perindopril) 4 mg or HCTZ ( hydrochlorothiazide) 12.5 mg.
At screening visit each patient will be genotyped for SNPs in preliminary genetic profiles with a custom SNP array. The therapy scheme includes 2-4-week run-in period after which eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg. Titration to Peri 8 mg or HCTZ 25 mg could be possible after one month treatment. Patients without any genetic profile will be randomly assigned to HCTZ or Peri treatment as control groups. The treatment period will last 8 weeks, while the study about 10-12 weeks Four cases may occur: * patient with HCTZ profile, HCTZ treatment; * patient with Peri profile, Peri treatment; * patient without HCTZ nor Peri profile, randomization for HCTZ or Peri; * patient with both profiles, treatment according to the profile with the higher number of positive contributors. Eligible patients will be treated according to their genetic profile with Peri 4 mg or HCTZ 12.5 mg/die. Titration to Peri 8 mg or HCTZ 25 mg could be possible after 4 weeks treatment. The treatment period will last 8 weeks, while the study about 10-12 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Azienda Sanitaria 6
Livorno, Italy
RECRUITINGSan Raffaele Hospital
Milan, Italy
RECRUITINGAzienda Ospedaliero - Universitaria S. Maria della Misericordia
Udine, Italy
NOT_YET_RECRUITINGSBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response
Difference in SBP and DBP variation after 4 and 8 weeks of therapy according to the presence or not of specific genetic profile for each drugs
Time frame: 4 and 8 weeks
Profiles implementation
Implementing and redefining the genetic profile for HCTZ or/and Peri by using a further spectrum of 128 different SNP variants
Time frame: in the three months after the end of the study
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