Arterial hypertension MedDRA version: 20.0 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866
Conditions
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for the main study (short-term study): 1. Provision of informed consent prior to any study specific procedures 2. Men or post-menopausal women that express their willing to participate in the study by signing the informed consent 3. Subjects aged 30-69 years (inclusive) 4. T2DM patients with adequate glucose control (HbA1c140/90 mmHg or home BP >135/85 mmHg despite a therapeutic dose of ACE-inhibitors Inclusion criteria for the substudy (acute study): 1. Provision of informed consent prior to any study specific procedures 2. Men or post-menopausal women that express their willing to participate in the study by signing the informed consent 3. Subjects aged 30-69 years (inclusive) 4. T2DM patients with adequate glucose control (HbA1c140/90 mmHg or home BP >135/85 mmHg), in whose according to guidelines antihypertensive treatment is not yet compelling Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Clinic BP values > 160/100 mmHg • eGFR3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN • Total bilirubin >2.0 mg/dL (34.2 µmol/L) • Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody • Volume depleted patients or those who, in the judgement of the investigator, may be at risk for dehydration (use of other diuretics, laxatives, chronic diarrhoea etc) • History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin cancer • Patients unable to give a valid informed consent; • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; • Patients who received any investigational new drug within the last 12 weeks; • Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of this project will be to evaluate the effect short-term (4 weeks) administration of dapagliflozin as compared to a thiazide diuretic on endothelial function as flow mediated dilation (FMD) of the brachial artery.;Secondary Objective: a) To assess the effects of short-term (4 weeks) treatment period with the two treatments on the following parameters: •Renal Resistive Index (RRI) before and after nitrate administration •Endothelial function as flow mediated dilation (FMD) of brachial artery •Carotid to femoral pulse wave velocity •Peripheral and Central BP measurement •24h BP monitoring •24h urinary albumin excretion •24h diuresis for glucose, Na, K, Cl, Ca, Mg urinary excretion determination •Free water clearance and Na fractional excretion •PRA, aldosterone, catecholamines plasma levels •Daily glucose profile (7 determination in a day) Safety objective •Adverse events and adverse drug reactions •Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula starting from serum creatinine) • Routine laboratory parameters (haematology, blood chemistry and urinalysis).;Primary end point(s): Change in endothelial function of the brachial artery, measured as flow mediated dilation (FMD), after 4-week administration of dapagliflozin or hydrochlorothiazide (short-term study).;Timepoint(s) of evaluation of this end point: 4 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints (adverse events and adverse drug reactions: eGFR haematology and blood chemistry laboratory parameters and urinalysis).;Timepoint(s) of evaluation of this end point: 4 WEEKS | — |
Countries
Italy
Contacts
Public ContactU.O. MEDICINA INTERNA III
AZIENDA OSPEDALIERO UNIVERSITARIA PISANA
Outcome results
None listed