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Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT) (PGX-HT)

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ClinicalTrials.gov Identifier: NCT03249285
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Chiara Lanzani, 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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Peri Drug: HCTZ Phase 3

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peri profile yes
patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Drug: Peri
Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
Other Name: Perindopril

Experimental: HCTZ profile yes
patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Drug: HCTZ
Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
Other Name: Hydrochlorothiazide

Active Comparator: Peri no profile
patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Drug: Peri
Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
Other Name: Perindopril

Active Comparator: HCTZ no profile
patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Drug: HCTZ
Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
Other Name: Hydrochlorothiazide




Primary Outcome Measures :
  1. SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response [ Time Frame: 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 :
  1. Profiles implementation [ Time Frame: 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



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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249285


Contacts
Contact: Lanzani Chiara, Doctor +390226435330 lanzani.chiara@hsr.it
Contact: Brioni Elena, Nurse +390226432876 brioni.elena@hsr.it

Locations
Italy
Azienda Sanitaria 6 Recruiting
Livorno, Italy, 57121
Contact: Bigazzi Roberto         
San Raffaele Hospital Recruiting
Milan, Italy, 20131
Contact: Lanzani L Chiara, Doctor    +390226435330    lanzani.chiara@hsr.it   
Contact: Brioni Elena, Nurse    +390226432876    brioni.elena@hsr.it   
Sub-Investigator: Simonini Marco, Doctor         
Sub-Investigator: Tentori Stefano, Doctor         
Azienda Ospedaliero - Universitaria S. Maria della Misericordia Not yet recruiting
Udine, Italy, 33170
Contact: Leonardo A Sechi         
Sponsors and Collaborators
Ospedale San Raffaele
Investigators
Study Chair: Manunta Paolo, Professor Scientif Institute San Raffale

Responsible Party: Chiara Lanzani, medical doctor, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT03249285     History of Changes
Other Study ID Numbers: udraCT NUMBER: 2015-001888-39
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chiara Lanzani, Ospedale San Raffaele:
hypertension
pharmacogenomics
anti-hypertensive therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Perindopril
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors