Pharmacogenetics of hypertension: study with Spironolactone or Torasemide

Pharmacogenetics of hypertension: randomized monocentric study in patients with essential hypertension and treated with Spironolactone or Torasemide - Pharmacogenetics of hypertension: study with Spironolactone or Torasemide

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001014-37-IT

Enrollment

144

Registered

2020-10-21

Start date

2020-08-13

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential hypertension MedDRA version: 22.1 Level: LLT Classification code 10015489 Term: Essential hypertension, benign System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: Torasemide Product Code: [Torasemide] Pharmaceutical Form: Tablet INN or Proposed INN: TORASEMIDE CAS Number: 56211-40-6 Current Sponsor code: Torasemide Other descriptive name: Torsemid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a. male patients aged 25-65 years and female patients aged 45-65 years in menopause b. naïve hypertensive patients (newly diagnosed, never previously treated) or in therapy with a single anti-hypertensive drug c. documented hypertension of grade I or II (according to ESH 2013 guidelines, in the untreated patient or despite the therapy). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 144 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a. known causes of secondary hypertension b. stage II hypertension (SBP = 180 and DBP = 110 mmHg; c. history of renal artery stenosis d. significant kidney disease (eGFR-CK-EPI less than 60 ml/min) e. refractory hypokalaemia or hyponatraemia (plasma Na 5.5 mEq/L) g. hypercalcaemia h. symptomatic hyperuricemia i. liver disease (transaminases greater than 3 times the maximum laboratory value) j. cardiac pathologies (previous myocardial infarction, ongoing atrial fibrillation, etc.) k. diabetes (fasting blood sugar > 126mg/dL) l. treatment with statins in progress m. obesity (BMI > 30 kg/m2) n. known hypersensitivity to the study drugs (Spironolactone or Torasemide) or to any of the excipients

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the difference in the reduction of systolic blood pressure (SBP) values between carriers and non-carriers of the different genotypic combinations for LSS and UMOD in response to Spironolactone or Torasemide after 4 weeks of treatment (T4 vs. T0);Secondary Objective: a. to evaluate the difference in the reduction of diastolic blood pressure (DBP) values after 4 weeks of treatment in the different genotypic groups (T4 vs. T0). b. to measure the changes in aldosterone and endogenous ouabain levels in the different genotypic groups after 4 weeks of treatment (T4 vs T0).;Primary end point(s): Changes in systolic blood pressure after treatment with one of the two drugs;Timepoint(s) of evaluation of this end point: 1 month	—

Measure

Time frame

Main Objective: To evaluate the difference in the reduction of systolic blood pressure (SBP) values between carriers and non-carriers of the different genotypic combinations for LSS and UMOD in response to Spironolactone or Torasemide after 4 weeks of treatment (T4 vs. T0);Secondary Objective: a. to evaluate the difference in the reduction of diastolic blood pressure (DBP) values after 4 weeks of treatment in the different genotypic groups (T4 vs. T0). b. to measure the changes in aldosterone and endogenous ouabain levels in the different genotypic groups after 4 weeks of treatment (T4 vs T0).;Primary end point(s): Changes in systolic blood pressure after treatment with one of the two drugs;Timepoint(s) of evaluation of this end point: 1 month

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in diastolic blood pressure, plasma aldosterone and ouabain values after treatment with one of the two drugs;Timepoint(s) of evaluation of this end point: 1 month	—

Countries

Italy

Contacts

Public ContactAmbulatorio Ipertensione - Nefrolog

IRCCS Ospedale San Raffaele

lanzani.chiara@hsr.it0226432384

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026