Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant

Last updated: May 11, 2024
Sponsor: Ospedale San Raffaele
Overall Status: Completed

Phase

3

Condition

Circulation Disorders

Vascular Diseases

Stress

Treatment

Amiloride

Clinical Study ID

NCT06416735
ADD-AMI
  • Ages 18-60
  • Male

Study Summary

The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male patients aged 18-60 years;

  • naïve hypertensive patients: newly diagnosed, never previously treated forhypertension;

  • BMI<30 Kg/m2,

  • documented first degree essential arterial hypertension (mean of the last 3consecutive 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 relativeconsent) and genotyped for the ADD1 rs4961 variant (GG, GT or TT).

Exclusion

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 -

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Amiloride
Phase: 3
Study Start date:
September 28, 2018
Estimated Completion Date:
July 20, 2020

Study Description

The study is carried out to evaluate primarily the difference in the activity of the renal transporter ENaC (through dosage of sodium) through its inhibition with a single dose of Amiloride in hypertensive patients characterized by the polymorphism of alpha Adducin rs496. It's also aimed to see the difference in potassium and the change in systolic and diastolic blood pressure after amiloride administration

Connect with a study center

  • San Raffaele Hospital

    Milan, Lombardia 20132
    Italy

    Site Not Available

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