Calcium Channel Blockade in Primary Aldosteronism

2019P003194

Primary aldosteronism is a common cause of hypertension. Recent evidence suggests that many patients with bilateral idiopathic hyperaldosteronism harbor gain-of-function somatic mutations in zona glomerulosa calcium channels that results in aldosterone production. This finding raises the possibility that calcium channel antagonists may be a targeted therapy to reduce aldosterone production in patients who harbor these mutations.

2020-09-01

2023-12-30

2023-12-30

Completed

Early phase I

15

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, single group, pilot intervention to evaluate physiologic changes in hormonal parameters.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

2024-01-18