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

Genetic Hypertension Clinical Trial

— ADD-AMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06416735
• Other study ID #: ADD-AMI
• Status: Completed
• Phase: Phase 3
• Start date: September 28, 2018
• Est. completion date: July 20, 2020

Study information

• Verified date: May 2024
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Genetic Hypertension
• Hypertension

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate urinary sodium	Evaluation of sodium levels after oral administration of Amiloride	3 hrs and 6 hrs
Secondary	Evaluate potassium levels	Evaluation of potassium plasma levels after oral administration of Amiloride	3 hrs and 6 hrs
Secondary	Evaluation of systolic blood pressure	Evaluation of systolic blood pressure after oral administration of Amiloride	3 hrs and 6 hrs
Secondary	Evaluation of diastolic blood pressure	Evaluation of diastolic blood pressure after oral administration of Amiloride	3 hrs and 6 hrs