Pharmacogenetics of hypertension: study with Spironolactone or Torasemide

Phase 1

• Conditions: Essential hypertension; MedDRA version: 22.1Level: LLTClassification code 10015489Term: Essential hypertension, benignSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 21.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-001014-37-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 144

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

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 < 126 mEq/L)
f. hyperkalaemia (plasma K > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>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 Outcome Measures

Name	Time	Method
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