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CompletedNCT06416735ADD-AMIUpdated May 16, 2024

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

A Phase 3 interventional study of Amiloride in Hypertension Essential, Salt Excess and Genetic Hypertension, sponsored by Ospedale San Raffaele. Completed at 1 site in Italy. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Ospedale San Raffaele · Phase 3, Interventional, and Other

From the registry’s dates

  • Primary completion was Jul 2020, 6 years 2 months ago, and no results have been posted to the registry.
  • Registered 4 years 11 months after the study started (first participant enrolled Sep 2018, registered Sep 2023).
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Hypertension Essential
  • Salt Excess
  • Genetic Hypertension

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Keywords

  • Hypertension
  • Salt
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Ospedale San Raffaele is the lead sponsor of 46 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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 -
05

Study design

Phase
Phase 3
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    patients carrying the wild-type (GG) genotype of ADD1 rs4961

    The protocol involves a test of oral administration of a single dose of Amiloride (5 or 10 mg based on body weight) to 20 patients carrying the wild-type (GG) genotype of ADD1 rs4961

    Drug: Amiloride

  • Experimental
    patients carriers of variant T (GT or TT)

    The test involves the administration of a single dose of 5 or 10 mg of Amiloride to 20 hypertensive carriers of the T variant (GT or TT)

    Drug: Amiloride

Interventions

  • DrugAmiloride

    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

06

What researchers measure

Primary outcomes

  1. Evaluate urinary sodium

    Evaluation of sodium levels after oral administration of Amiloride

    Time frame: 3 hrs and 6 hrs

Secondary outcomes

  1. Evaluate potassium levels

    Evaluation of potassium plasma levels after oral administration of Amiloride

    Time frame: 3 hrs and 6 hrs

  2. Evaluation of systolic blood pressure

    Evaluation of systolic blood pressure after oral administration of Amiloride

    Time frame: 3 hrs and 6 hrs

  3. Evaluation of diastolic blood pressure

    Evaluation of diastolic blood pressure after oral administration of Amiloride

    Time frame: 3 hrs and 6 hrs

07

Study locations

1 site
  • San Raffaele Hospital
    Milan, Lombardia 20132, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06416735
Lead sponsor
Ospedale San Raffaele
Responsible party
Chiara Lanzani (medical doctor in nephrology unit, nephrologist, Ospedale San Raffaele) — Principal investigator
First posted
May 16, 2024
Start date
Sep 28, 2018
Primary completion
Jul 20, 2020
Completion
Jul 20, 2020
Last update
May 16, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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