Calcium Channel Blockade in Primary Aldosteronism

NCT04179019 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2019P003194
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Aldosteronism; Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Keywords

primary aldosteronism; calcium channel blocker

Outcome Measures

Primary Outcomes (2)

• Change in 24-hour Urinary Aldosterone Excretion Rate

  Change in 24h urinary aldosterone excretion rate in response to maximal amlodipine therapy

  Baseline and 2 weeks of amlodipine therapy

• Change in Plasma Aldosterone Concentration

  Change in plasma aldosterone concentration in response to maximal amlodipine therapy

  Baseline and 2 weeks of amlodipine therapy

Secondary Outcomes (1)

• Acute Change in Plasma Aldosterone Concentration

  Baseline plasma aldosterone concentration before amlodipine therapy and 6 hours post-amlodipine dose, compared to baseline plasma aldosterone after 2 weeks of amlodipine therapy and 6 hours post-amlodipine therapy.

Study Arms (1)

Amlodipine

EXPERIMENTAL

Amlodipine (dose 10 mg, once daily)

Drug: Amlodipine

Interventions

Amlodipine DRUG

Amlodipine (10mg daily, as tolerated by blood pressure parameters) for 2 weeks

Amlodipine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Michigan: collaborator

Study Sites (1)

Anand Vaidya

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The major limitations of this pilot study was that it was intended to be a small proof-of-concept study in 15 people with advanced primary aldosteronism given the multi-morbidity nature of this population and difficulty in enrolling them. Further, this was a single-arm study without a control group. Finally, largely influenced by the concurrent COVID pandemic in 2020-2022, only 2 participants completed the pilot study, therefore validity of the results is low.

Results Point of Contact

• Title: Anand Vaidya
• Organization: Brigham and Women's Hospital

anandvaidya@bwh.harvard.edu

6177325666

Study Officials

• Anand Vaidya, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Open-label, single group, pilot intervention to evaluate physiologic changes in hormonal parameters.

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 26, 2019
• Study Start: September 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year after the completion of the study
• Access Criteria: clinical researchers with local institutional ethics approval

Locations

US (1)