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Completed

NCT Number: NCT06416735

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

San Raffaele Hospital

Milan, Lombardy, 20132, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Amiloride

Drug

administration of a single dose of 5 or 10 mg of Amiloride (based on body weight) After oral intake of the drug, the increase in sodium in the urine ends within 8 hours

Primary outcomes

  1. Evaluate urinary sodium

    Time frame: 3 hrs and 6 hrs

    Evaluation of sodium levels after oral administration of Amiloride

Secondary outcomes

  1. Evaluate potassium levels

    Time frame: 3 hrs and 6 hrs

    Evaluation of potassium plasma levels after oral administration of Amiloride

  2. Evaluation of systolic blood pressure

    Time frame: 3 hrs and 6 hrs

    Evaluation of systolic blood pressure after oral administration of Amiloride

  3. Evaluation of diastolic blood pressure

    Time frame: 3 hrs and 6 hrs

    Evaluation of diastolic blood pressure after oral administration of Amiloride

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Registry information

Official study title

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

Acronym: ADD-AMI

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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