Pharmacogenetics of Torasemide and Spironolactone in Hypertension Treatment (ALTUM)

San Donato Group (GSD)

Status and phase

Completed

Phase 3

Conditions

Hypertension

Genetic Predisposition

Drug Effect

Treatments

Drug: Spironolactone

Drug: Torasemide

Study type

Interventional

Funder types

Other

Identifiers

NCT06413082

ALTUM

Details and patient eligibility

About

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

Full description

The investigators will enroll 144 naïve hypertensive subjects who will undertake 2-4 weeks of run-in and 4 weeks of treatment (7 day window at each visit). During this period partecipants will follow a low sodium diet (about 5g/day) and will be monitored with blood chemistry tests

Enrollment

38 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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