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

NCT ID: NCT06416735

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-28
• Study Completion Date: 2020-07-20

Brief Summary

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

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

Conditions

Hypertension Essential; Salt Excess; Genetic Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Amiloride

Intervention Type: 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

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)

Group Type: EXPERIMENTAL

Amiloride

Intervention Type: 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

Interventions

Amiloride

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

Intervention Type: DRUG

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Chiara Lanzani

medical doctor in nephrology unit, nephrologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

San Raffaele Hospital

Milan, Lombardy, Italy

Countries

Italy

Other Identifiers

ADD-AMI

Identifier Type: -

Identifier Source: org_study_id