Clinical trial NCT03249285: Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)
Official title: Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
pharmacogenomics
anti-hypertensive therapy
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Male/Female patients aged 25-60 years.
* Naive hypertensive patients (newly diagnosed, never treated before).
* Documented mild to moderate arterial hypertension, as defined below:

  1. 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);
  2. 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response
timeFrame: 4 and 8 weeks
Secondary outcomes:
measure: Profiles implementation
timeFrame: in the three months after the end of the study
Other outcomes:
Locations:
city: Livorno
country: Italy
facility: Azienda Sanitaria 6
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Udine
country: Italy
facility: Azienda Ospedaliero - Universitaria S. Maria della Misericordia
Study officials:
affiliation: Scientif Institute San Raffale
name: Manunta Paolo, Professor
role: STUDY_CHAIR
References: