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.
Investigators
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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