Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)

NCT ID: NCT03249285

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-11-30

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peri profile yes

patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks

Group Type: EXPERIMENTAL

Peri

Intervention Type: DRUG

Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled

HCTZ profile yes

patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks

Group Type: EXPERIMENTAL

HCTZ

Intervention Type: DRUG

Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled

Peri no profile

patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks

Group Type: ACTIVE_COMPARATOR

Peri

Intervention Type: DRUG

Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled

HCTZ no profile

patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks

Group Type: ACTIVE_COMPARATOR

HCTZ

Intervention Type: DRUG

Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled

Interventions

Peri

Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled

Intervention Type: DRUG

HCTZ

Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled

Intervention Type: DRUG

Other Intervention Names

Perindopril; Hydrochlorothiazide

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Chiara Lanzani

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manunta Paolo, Professor

Role: STUDY_CHAIR

Scientif Institute San Raffale

Locations

Azienda Sanitaria 6

Livorno, , Italy

Site Status: RECRUITING

San Raffaele Hospital

Milan, , Italy

Site Status: RECRUITING

Azienda Ospedaliero - Universitaria S. Maria della Misericordia

Udine, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Lanzani Chiara, Doctor

Role: CONTACT

lanzani.chiara@hsr.it

+390226435330

Brioni Elena, Nurse

Role: CONTACT

brioni.elena@hsr.it

+390226432876

Facility Contacts

Bigazzi Roberto

Role: primary

Lanzani L Chiara, Doctor

Role: primary

lanzani.chiara@hsr.it

+390226435330

Brioni Elena, Nurse

Role: backup

brioni.elena@hsr.it

+390226432876

Leonardo A Sechi

Role: primary

Other Identifiers

udraCT NUMBER: 2015-001888-39

Identifier Type: -

Identifier Source: org_study_id