Calcium Channel Blockade in Primary Aldosteronism

• Status: Recruiting
• Trial end date: 2025-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: University of Michigan
• Treatments: Amlodipine; Calcium

Criteria

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