Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant (NCT06416735) | Clinical Trial Compass
CompletedPhase 3
Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
Italy40 participantsStarted 2018-09-28
Plain-language summary
The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
Who can participate
Age range18 Years – 60 Years
SexMALE
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Inclusion Criteria:
* male patients aged 18-60 years;
* naïve hypertensive patients: newly diagnosed, never previously treated for hypertension;
* BMI\<30 Kg/m2,
* documented first degree essential arterial hypertension (mean of the last 3 consecutive systolic BP measurements must be \>=140 mmHg or diastolic BP \>=90 mmHg;
* signature of the informed consent for participation in the study
* patient who has already undergone genomic DNA sampling (accompanied by relative consent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT).
Exclusion Criteria:
known causes of secondary hypertension;
* severe or malignant hypertension; history of renal artery disease;
* significant renal disease (creatinine clearance less than 60 ml/min);
* hyperkalemia (Kpl \> 6mEq/l) at enrollment visit;
* hypercalcaemia (Ca pl \> 2.6 mmol/l) at enrollment visit;
* symptomatic hyperuricemia (\> 7.5 mg/dl);
* liver disease (transaminases greater than 3 times the normal value);
* cardiac pathologies (myocardial infarction, atrial fibrillation, etc.);
* diabetes (fasting blood sugar \>125mg/dl);
* in therapy with statins, NSAIDs, systemic steroids;
* known hypersensitivity to Amiloride or to any of the excipients;
* patients unable to express a valid consent -