CompletedPhase 2

Calcium Channel Blockade in Primary Aldosteronism

United States15 participantsStarted 2020-09-01

Plain-language summary

This pilot study explore whether the calcium channel blocker amlodipine can lower aldosterone levels in people with primary aldosteronism.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

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: * Confirmed diagnosis of primary aldosteronism * Idiopathic bilateral hyperaldosteronism subtype based on adrenal venous sampling * Primary aldosteronism treated with medical therapy (not surgery) * Plasma renin activity \<1.0 ng/mL/h Exclusion Criteria: * large or discrete adrenal adenoma on cross-sectional imaging * inability to stop calcium channel blocker and transition to alternative medication * inability to stop mineralocorticoid receptor antagonist and transition to alternative medication if plasma renin activity \> 1.0 ng/mL/h * Anemia * leukopenia * thrombocytopenia * pregnant * breastfeeding

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Change in 24-hour Urinary Aldosterone Excretion Rate

Timeframe: Baseline and 2 weeks of amlodipine therapy

Change in Plasma Aldosterone Concentration

Timeframe: Baseline and 2 weeks of amlodipine therapy

Trial details

NCT IDNCT04179019

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

Results submitted2025-03-10

View on ClinicalTrials.gov More Primary Aldosteronism trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.