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

NCT06416735 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: ADD-AMI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension Essential; Salt Excess; Genetic Hypertension

Keywords

Hypertension; Salt

Outcome Measures

Primary Outcomes (1)

• Evaluate urinary sodium

  Evaluation of sodium levels after oral administration of Amiloride

  3 hrs and 6 hrs

Secondary Outcomes (3)

• Evaluate potassium levels

  3 hrs and 6 hrs

• Evaluation of systolic blood pressure

  3 hrs and 6 hrs

• Evaluation of diastolic blood pressure

  3 hrs and 6 hrs

Study Arms (2)

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

EXPERIMENTAL

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

patients carriers of variant T (GT or TT)

EXPERIMENTAL

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

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

patients carriers of variant T (GT or TT); patients carrying the wild-type (GG) genotype of ADD1 rs4961

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, Lombardy, 20132, Italy

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Amiloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor in nephrology unit, nephrologist

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

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: May 16, 2024
• Study Start: September 28, 2018
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

IT (1)