Effect of a Proposed Cav1.3 Inhibitor in Primary Aldosteronism - a Pilot Study

154739

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.

2023-05-05

2024-04-06

2024-05-06

Active (not recruiting)

15

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}

2024-02-12