Pharmacogenetics of Hypertension: a Single-centre Randomized Study in Patients With Essential Hypertension Treated With Spironolactone or Torasemide

ALTUM

Phase III interventional study to evaluate the different efficacy of Torasemide and Spironolactone in reducing systolic blood pressure in carriers and non-carriers of the different genotypic combinations for Lanosterol and Uromodulin

2021-02-15

2023-07-07

2023-09-03

Completed

Early phase I

38

Inclusion Criteria: * male (25-65 years) and female (45-65 years in menopause defined as "12 consecutive months of amenorrhea for which no other physiological or pathological cause has been identified in woman over 45 years of age") * newly diagnosed hypertensive patients never treated before or on single antihypertensive drug therapy * hypertension grade I or II (according to 2013 ESH guidelines, in the patient untreated or despite therapy), defined as the following: * at visits T-4 and T-2 (week -4 and week -2 ± 7 days, run-in period) the mean of the last 3 consecutive SBP measurements must be \>=140 mmHg and/or diastolic BP\>= 90mmHg * at the T0 visit (week 0 ± 7 days, enrollment), the mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg and \<180 mmHg and diastolic BP must be \>=90 mmHg and \<110 mmHg * signing of the informed consent for participation in the study and for genotyping. Exclusion Criteria: * known causes of secondary hypertension * stage II hypertension (SBP\>= 180 and SBP\>=110 mmHg * history of renal artery stenosis * significant kidney disease (eGFR-CK-EPI less than 60 mL/min) * refractory hypokalemia or hyponatremia (Napl \< 126 mEq/L) * hyperkalemia (K \> 5.5 mEq/l) * hypercalcemia * symptomatic hyperuricemia * liver disease (transaminases greater than 3 times the maximum laboratory value) * cardiac pathologies (previous myocardial infarction, atrial fibrillation in progress, etc.) * diabetes (fasting blood sugar \>126mg/dL) -. current statin treatment * obesity (BMI \>30 kg/m2) * ongoing pregnancy * breastfeeding in progress * anuria * hypovolemia and dehydration * known hypersensitivity to the study drugs (Spironolactone or Torasemide) or to any of the excipients * ongoing therapy with aminoglycosides or cephalosporins * participation in a clinical study in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug * patients unable to express valid consent

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2024-05-16