Trial Outcomes & Findings for Calcium Channel Blockade in Primary Aldosteronism (NCT NCT04179019)

NCT ID: NCT04179019

Last Updated: 2025-04-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline and 2 weeks of amlodipine therapy
• Results posted on: 2025-04-15

Participant Flow

Participants were recruited from the hospital clinics for a diagnosis of known primary aldosteronism

Prior to assignment, participants taking calcium channel blockers had to to stop these medications for 2-4 weeks. During this time, BP was managed with doxazosin and/or hydralazine to target an ideal range of <130/80 mmHg, but practically ranges of 120-150/60-90 mmHg. In addition, Serum potassium had to be between 3.5-4.5 mEq/L and plasma renin activity had to be <1.0 ng/mL/h, prior to initiation of the study. The inability to achieve these outcomes may result in withdrawal.

Participant milestones

Measure	Amlodipine Amlodipine (dose 10 mg, once daily)
Overall Study STARTED	15
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Amlodipine Amlodipine (dose 10 mg, once daily)
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	5
Overall Study Adverse Event	4

Baseline Characteristics

Calcium Channel Blockade in Primary Aldosteronism

Baseline characteristics by cohort

Measure	Amlodipine n=15 Participants Amlodipine (dose 10 mg, once daily)
Age, Continuous	58.9 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2 weeks of amlodipine therapy

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

Outcome measures

Measure	Amlodipine n=2 Participants Amlodipine (dose 10 mg, once daily) Amlodipine: Amlodipine (10mg daily, as tolerated by blood pressure parameters) for 2 weeks
Change in 24-hour Urinary Aldosterone Excretion Rate	0.21 mcg/24h Standard Deviation 4.94

PRIMARY outcome

Timeframe: Baseline and 2 weeks of amlodipine therapy

Change in plasma aldosterone concentration in response to maximal amlodipine therapy

Outcome measures

Measure	Amlodipine n=2 Participants Amlodipine (dose 10 mg, once daily) Amlodipine: Amlodipine (10mg daily, as tolerated by blood pressure parameters) for 2 weeks
Change in Plasma Aldosterone Concentration	9.81 ng/dL Standard Deviation 6.87

SECONDARY outcome

Timeframe: 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.

Change in plasma aldosterone concentration after a single dose of amlodipine, before and after 2 weeks of amlodipine therapy

Outcome measures

Measure	Amlodipine n=2 Participants Amlodipine (dose 10 mg, once daily) Amlodipine: Amlodipine (10mg daily, as tolerated by blood pressure parameters) for 2 weeks
Acute Change in Plasma Aldosterone Concentration	-0.86 ng/dL Standard Deviation 4.51

Adverse Events

Amlodipine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Amlodipine n=15 participants at risk Amlodipine (dose 10 mg, once daily)
Vascular disorders elevated blood pressure	6.7% 1/15 • Number of events 1 • During the course of the study, ranging from 2-8 weeks
Endocrine disorders incidental abnormal labs	13.3% 2/15 • Number of events 2 • During the course of the study, ranging from 2-8 weeks
Cardiac disorders atypical chest pain unrelated to study protocol	6.7% 1/15 • Number of events 1 • During the course of the study, ranging from 2-8 weeks
Renal and urinary disorders hematuria unrelated to the study protocol or procedures	6.7% 1/15 • Number of events 1 • During the course of the study, ranging from 2-8 weeks

Additional Information

Anand Vaidya

Brigham and Women's Hospital

Phone: 6177325666

Email: anandvaidya@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place