## Protocol Section
### Identification Module
**NCT ID:** NCT06416735

**Acronym:** ADD-AMI

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

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

#### Organization Study ID Info
**ID:** ADD-AMI
#### Organization
**Class:** OTHER
**Full Name:** Ospedale San Raffaele
### Status Module
#### Completion Date
**Date:** 2020-07-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-07-20

**Type:** ACTUAL

#### Start Date
**Date:** 2018-09-28

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-04
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ospedale San Raffaele

#### Responsible Party

**Investigator Affiliation:** Ospedale San Raffaele

**Investigator Full Name:** Chiara Lanzani

**Investigator Title:** medical doctor in nephrology unit, nephrologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Hypertension Essential

- Salt Excess

- Genetic Hypertension

**Keywords:**

- Hypertension

- Salt

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Drug: Amiloride

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

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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)

**Intervention Names:**

- Drug: Amiloride

**Label:** patients carriers of variant T (GT or TT)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- patients carriers of variant T (GT or TT)

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

**Description:** 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

**Name:** Amiloride

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of sodium levels after oral administration of Amiloride

**Measure:** Evaluate urinary sodium

**Time Frame:** 3 hrs and 6 hrs

#### Secondary Outcomes

**Description:** Evaluation of potassium plasma levels after oral administration of Amiloride

**Measure:** Evaluate potassium levels

**Time Frame:** 3 hrs and 6 hrs

**Description:** Evaluation of systolic blood pressure after oral administration of Amiloride

**Measure:** Evaluation of systolic blood pressure

**Time Frame:** 3 hrs and 6 hrs

**Description:** Evaluation of diastolic blood pressure after oral administration of Amiloride

**Measure:** Evaluation of diastolic blood pressure

**Time Frame:** 3 hrs and 6 hrs

### Eligibility Module

**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 -

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Milan

**Country:** Italy

**Facility:** San Raffaele Hospital

**State:** Lombardia

**Zip:** 20132

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Ancestors

- ID: D000004232

- Term: Diuretics

- ID: D000045283

- Term: Natriuretic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000062646

- Term: Acid Sensing Ion Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000062686

- Term: Epithelial Sodium Channel Blockers

- ID: D000062865

- Term: Diuretics, Potassium Sparing

### Intervention Browse Module - Browse Branches

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M3925

- Name: Amiloride

- Relevance: HIGH

- As Found: Heart Valve

- ID: M7411

- Name: Diuretics

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000584

- Term: Amiloride

### Misc Info Module

- Version Holder: 2024-05-31
