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 range18 Years – 80 Years

SexALL

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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

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