Hypertension EssentialPhase 3ADD-AMINCT06416735
Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
A Phase 3 study testing Amiloride in people with Hypertension Essential and Salt Excess, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Hypertension Essential, Salt Excess, Genetic Hypertension
- What is being tested?
- Amiloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 28 Sep 2018to 20 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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);
Show all 12Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natriruetic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
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
- Conditions
- Hypertension Essential, Salt Excess, Genetic Hypertension
- Being tested
- Amiloride
- Keywords
- Hypertension, Salt
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmilorideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Drug: Amiloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate urinary sodium
Evaluation of sodium levels after oral administration of Amiloride
Measured: 3 hrs and 6 hrs
Secondary outcomes (3)
Evaluate potassium levels
Evaluation of potassium plasma levels after oral administration of Amiloride
Measured: 3 hrs and 6 hrs
Evaluation of systolic blood pressure
Evaluation of systolic blood pressure after oral administration of Amiloride
Measured: 3 hrs and 6 hrs
Evaluation of diastolic blood pressure
Evaluation of diastolic blood pressure after oral administration of Amiloride
Measured: 3 hrs and 6 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start28 Sep 2018
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Lanzani, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416735
- Sponsor's protocol ID
- ADD-AMI
- Acronym
- ADD-AMI
- Status last verified
- May 2024
- First submitted
- 4 Sep 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natriruetic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
- ClinicalTrials.gov ID
- NCT06416735
- Acronym / sponsor ID
- ADD-AMI / ADD-AMI
- Conditions
- Hypertension Essential, Salt Excess, Genetic Hypertension
- Keywords
- Hypertension, Salt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
| Arm | Type | Receives |
|---|---|---|
| patients carrying the wild-type (GG) genotype of ADD1 rs4961 | Experimental | Drug: AmilorideThe 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 |
| patients carriers of variant T (GT or TT) | Experimental | Drug: AmilorideThe 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amilorideadministration 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 | Drug | patients carriers of variant T (GT or TT), patients carrying the wild-type (GG) genotype of ADD1 rs4961 |
Primary outcome
Evaluate urinary sodium
Time frame: 3 hrs and 6 hrs
Evaluation of sodium levels after oral administration of Amiloride
3 secondary outcomes
Evaluate potassium levels
Time frame: 3 hrs and 6 hrs
Evaluation of systolic blood pressure
Time frame: 3 hrs and 6 hrs
Evaluation of diastolic blood pressure
Time frame: 3 hrs and 6 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Related trials for Hypertension Essential
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiloride in people with Hypertension Essential and Salt Excess, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate urinary sodium (time frame: 3 hrs and 6 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.