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Clinical Trials/EUCTR2020-001014-37-IT
EUCTR2020-001014-37-IT
Active, not recruiting
Phase 1

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

OSPEDALE SAN RAFFAELE0 sites144 target enrollmentOctober 21, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
OSPEDALE SAN RAFFAELE
Enrollment
144
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 21, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
OSPEDALE SAN RAFFAELE

Eligibility 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

  • 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.)

Outcomes

Primary Outcomes

Not specified

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