Effect of a Proposed Cav1.3 Inhibitor in Primary Aldosteronism

NCT05686993 | Completed

• 1 other identifier: 154739
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot, open-label prospective study is to evaluate if the effect of calcium channel blockade on plasma aldosterone levels in people with primary aldosteronism (PA) is due primarily to Cav1.3 blockade. This will be tested by treating participants who have PA with both cinnarizine (Cav1.3 blocker) and nifedipine (Cav1.2 blocker) and evaluating effect on aldosterone levels and blood pressure over a two week course of treatment.

Conditions

Primary Aldosteronism; Endocrine Hypertension

Keywords

Primary aldosteronism; Calcium channel blocker; Aldosterone

Outcome Measures

Primary Outcomes (1)

• Aldosterone change

  Evaluate whether the effect of calcium channel blockade on plasma aldosterone levels is due primarily to Cav1.3 blockade in individuals with PA and clinical features suggesting an increased likelihood of a CACNA1D mutation.

  6 weeks

Secondary Outcomes (1)

• Blood pressure change

  6 weeks

Study Arms (1)

Cinnarizine and nifedipine

EXPERIMENTAL

Drug 1 for 2 weeks, 2 weeks of washout, then Drug 2 for 2 weeks Drug 1 and 2, in no specified order, Cinnarizine 30 mg oral TDS and Nifedipine 60 mg oral daily

Drug: Cinnarizine; Drug: NIFEdipine ER

Interventions

Cinnarizine DRUG

Cinnarizine oral 30mg TDS

Also known as: Stugeron, Stunarone, Cinarin

Cinnarizine and nifedipine

NIFEdipine ER DRUG

Nifedipine oral 60mg daily extended release

Also known as: Adalat, Adipine, Coracten, Fortipine, Nifedipress

Cinnarizine and nifedipine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed PA, as demonstrated by a positive screening test and internationally endorsed confirmatory test (saline suppression test, captopril challenge test)
• Adults \> 18 years of age
• Able and willing to give informed consent

You may not qualify if:

• Uncontrolled hypertension requiring use of MRA
• Unwilling or unable to give consent
• Below age 18 or above age 90 years
• Allergy to cinnarizine or nifedipine or their excipients
• Existing use of cinnarizine or nifedipine for an alternative indication
• Breastfeeding or pregnant women
• Diagnosis of Parkinson's disease
• Severe hepatic or renal insufficiency
• Concurrent use of sedating central nervous system (CNS) depressants or rifampicin
• Porphyria
• Cardiogenic shock, clinically significant aortic stenosis, unstable angina, within one month of a myocardial infarction
• Previous gastro-intestinal or oesophageal obstruction or ileostomy

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• Ng E, Lee YN, Taylor A, Shaheen F, Azizan E, Drake WM, Brown MJ. Evaluation of Aldosterone Suppression by Cinnarizine, a Putative Cav1.3 Inhibitor. J Clin Endocrinol Metab. 2025 Sep 16;110(10):2752-2761. doi: 10.1210/clinem/dgaf081.

  PMID: 40052842 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Cinnarizine; cynarine; Nifedipine

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Morris Brown, MD FRCP

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment with 2 study drugs with 2 weeks of drug washout in between Study drug treatments are: cinnarizine for 2 weeks, nifedipine for 2 weeks Order randomly determined by computer program, with results released by an independent clinician as patients are recruited

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 17, 2023
• Study Start: April 24, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 6, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)