Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant (NCT06416735) | Clinical Trial Compass
CompletedPhase 3
Natriuretic Effect of Amiloride in Relation to the Alpha Adducin Gene (ADD-AMI) RS4961 Variant
Italy40 participantsStarted 2018-09-28
Plain-language summary
The study is a non-pharmacological interventional, single-center, national, non-randomised, comparative and open label.
Who can participate
Age range
18 Years – 60 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 -
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focused on a specific gene variant called Alpha Adducin RS4961 — do I know whether I carry this variant, and could that affect how well a drug like amiloride might work for my blood pressure?
2Since this was a Phase 3 trial looking at how amiloride affects sodium excretion through urine, what does that actually mean for someone like me — does higher or lower sodium in the urine tell us whether the drug is working the way it should?
3The trial specifically studied essential hypertension in the context of salt intake — given my own salt consumption habits, is this kind of genetic-based approach to choosing a blood pressure medication something worth exploring for me?
4Since this trial is now completed, are there published results available that you could review to help decide whether amiloride might be a better or worse fit for me compared to other diuretics I might already be considering?
5Genetic factors seem to play a role in how this trial was designed — should I consider genetic testing as part of figuring out which blood pressure medications are most likely to work for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.