Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)
- Registration Number
- NCT03249285
- Lead Sponsor
- Ospedale San Raffaele
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
-
Male/Female patients aged 25-60 years.
-
Naive hypertensive patients (newly diagnosed, never treated before).
-
Documented mild to moderate arterial hypertension, as defined below:
- At Visits 1 and 2 (week -4 and week -2 run-in period) the mean of the last 3 consecutive readings of office SBP must be >= 140 mmHg and/or DBP must be >=90 mmHg, when measured by office blood pressure (OBP);
- At Visit 3 (week 0) enrolment , the mean of the last 3 consecutive readings of SBP must be >= 140 mmHg and <160 mmHg, and DBP must be >= 90 mmHg and <110 mmHg, when measured by OBP.
-
Signed informed consent for genotyping.
- known causes of secondary hypertension;
- pregnant, nursing women or women of childbearing potential taking anti-contraceptive medication;
- severe or malignant hypertension;
- history of renal artery disease;
- significant renal disease (estimated creatinine clearance less than 60 mL/min);
- hepatic disease;
- cardiac diseases (myocardial infarction, atrial fibrillation, etc);
- diabetes (fasting plasma glucose >125mg/dL);
- statin treatment;
- obesity (BMI>30 kg/m2).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peri no profile Peri patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks HCTZ no profile HCTZ patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks Peri profile yes Peri patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks HCTZ profile yes HCTZ patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
- Primary Outcome Measures
Name Time Method SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response 4 and 8 weeks 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
- Secondary Outcome Measures
Name Time Method Profiles implementation in the three months after the end of the study Implementing and redefining the genetic profile for HCTZ or/and Peri by using a further spectrum of 128 different SNP variants
Trial Locations
- Locations (3)
Azienda Sanitaria 6
🇮🇹Livorno, Italy
Azienda Ospedaliero - Universitaria S. Maria della Misericordia
🇮🇹Udine, Italy
San Raffaele Hospital
🇮🇹Milan, Italy