Back to resultsPharmacogenomics of Hypertension Personalized Medicine (PGX-HT) (PGX-HT)
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Peri
HCTZ
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, pharmacogenomics, anti-hypertensive therapy
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:
- 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.
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).
Sites / Locations
- Azienda Sanitaria 6Recruiting
- San Raffaele HospitalRecruiting
- Azienda Ospedaliero - Universitaria S. Maria della Misericordia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Peri profile yes
HCTZ profile yes
Peri no profile
HCTZ no profile
Arm Description
patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Outcomes
Primary Outcome Measures
SBP (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
Secondary Outcome Measures
Profiles implementation
Implementing and redefining the genetic profile for HCTZ or/and Peri by using a further spectrum of 128 different SNP variants
Full Information
NCT ID
NCT03249285
First Posted
February 13, 2017
Last Updated
August 10, 2017
Sponsor
Ospedale San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT03249285
Brief Title
Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)
Acronym
PGX-HT
Official Title
Pharmacogenomics Of Hypertension: A New Approach For A Personalized Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale San Raffaele
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, pharmacogenomics, anti-hypertensive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peri profile yes
Arm Type
Experimental
Arm Description
patient with genetic Perindopril profile, receiving Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Arm Title
HCTZ profile yes
Arm Type
Experimental
Arm Description
patient with genetic HCTZ profile, receiving HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Arm Title
Peri no profile
Arm Type
Active Comparator
Arm Description
patient with no genetic profile, receiving after randomisation Perindopril treatment with 4-8 mg/day oral for 4-8 weeks
Arm Title
HCTZ no profile
Arm Type
Active Comparator
Arm Description
patient with no genetic profile, receiving after randomisation HCTZ treatment with 12,5-25 mg/day oral for 4-8 weeks
Intervention Type
Drug
Intervention Name(s)
Peri
Other Intervention Name(s)
Perindopril
Intervention Description
Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
Intervention Type
Drug
Intervention Name(s)
HCTZ
Other Intervention Name(s)
Hydrochlorothiazide
Intervention Description
Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
Primary Outcome Measure Information:
Title
SBP (Systolic blood pressure) and DBP (Diastolic blood pressure) response
Description
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
Secondary Outcome Measure Information:
Title
Profiles implementation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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:
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.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lanzani Chiara, Doctor
Phone
+390226435330
Email
lanzani.chiara@hsr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Brioni Elena, Nurse
Phone
+390226432876
Email
brioni.elena@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manunta Paolo, Professor
Organizational Affiliation
Scientif Institute San Raffale
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Sanitaria 6
City
Livorno
ZIP/Postal Code
57121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bigazzi Roberto
Facility Name
San Raffaele Hospital
City
Milan
ZIP/Postal Code
20131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lanzani L Chiara, Doctor
Phone
+390226435330
Email
lanzani.chiara@hsr.it
First Name & Middle Initial & Last Name & Degree
Brioni Elena, Nurse
Phone
+390226432876
Email
brioni.elena@hsr.it
First Name & Middle Initial & Last Name & Degree
Simonini Marco, Doctor
First Name & Middle Initial & Last Name & Degree
Tentori Stefano, Doctor
Facility Name
Azienda Ospedaliero - Universitaria S. Maria della Misericordia
City
Udine
ZIP/Postal Code
33170
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo A Sechi
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pharmacogenomics of Hypertension Personalized Medicine (PGX-HT)
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