What is the mechanism of action of this treatment?

Conn Syndrome, or primary aldosteronism, is treated by reducing aldosterone production or blocking its effects. Common treatments include mineralocorticoid receptor antagonists like spironolactone and eplerenone, which block aldosterone's action, reducing sodium retention and potassium loss. Calcium channel antagonists, such as verapamil, inhibit calcium channels in the adrenal gland's zona glomerulosa, reducing aldosterone synthesis. This approach is crucial for Conn Syndrome patients as it targets the root cause, improving blood pressure control and electrolyte balance.

What side effects are associated with this type of intervention?

Common treatments for Conn Syndrome include mineralocorticoid receptor antagonists like spironolactone and eplerenone, which can cause hyperkalemia, gynecomastia, and menstrual irregularities. Calcium channel antagonists, which are being studied for their potential to reduce aldosterone production, may cause side effects such as hypotension, dizziness, peripheral edema, and in some cases, symptomatic hypocalcemia and cardiac suppression when used with other medications like magnesium sulfate. These side effects should be carefully monitored during treatment.

What prior FDA approvals exist?

Conn Syndrome, or primary aldosteronism, is typically treated with mineralocorticoid receptor antagonists such as spironolactone and eplerenone, which have been FDA-approved for this condition. These drugs work by blocking the effects of aldosterone. Recent research suggests that calcium channel antagonists, which inhibit calcium channels in the zona glomerulosa to reduce aldosterone production, may offer a targeted therapy for patients with specific somatic mutations. However, these calcium channel antagonists are still under investigation and have not yet received FDA approval for this specific use.

What other types of research exist?

Promising novel alternatives to calcium channel antagonists for Conn Syndrome patients include gene therapy to correct gain-of-function mutations in zona glomerulosa calcium channels, novel small molecule inhibitors targeting these specific mutations, and other hormonal modulators that reduce aldosterone production.

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Calcium Channel Blocker

Amlodipine for Primary Aldosteronism (CCB-PA Trial)

Phase 2

Waitlist Available

Led By Anand Vaidya, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if the drug amlodipine can help lower aldosterone levels in patients with a type of high blood pressure called primary aldosteronism. These patients have a condition where their adrenal glands produce too much aldosterone due to calcium channel mutations. By blocking these channels, amlodipine may reduce aldosterone production and improve blood pressure control. Amlodipine is a long-acting medication widely used for lowering elevated blood pressure and has shown cardiovascular benefits when combined with other blood pressure-lowering agents.

Who is the study for?

This trial is for adults with primary aldosteronism, a condition causing high blood pressure due to excess hormone production. Participants must have low plasma renin activity and be diagnosed with idiopathic bilateral hyperaldosteronism. They should be on medical therapy, not surgery, and able to switch from current calcium channel blockers or mineralocorticoid receptor antagonists if needed.

What is being tested?

The study tests Amlodipine, a calcium channel blocker, as a potential targeted treatment for reducing aldosterone production in patients with specific genetic mutations associated with primary aldosteronism.

What are the potential side effects?

Amlodipine may cause swelling of the legs or ankles, fatigue, stomach pain, dizziness, flushing (feeling warm), palpitations (irregular heartbeat), and in rare cases more serious heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 24-hour Urinary Aldosterone Excretion Rate

Change in Plasma Aldosterone Concentration

Secondary study objectives

Acute change in Plasma Aldosterone Concentration

Acute change in Systolic Blood pressure

Side effects data

From 2019 Phase 4 trial • 44 Patients • NCT02034435

Headache

numbness

Dizziness/Lightheadedness

viral illness

Low glucose

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Aim 1- Low Sodium

Aim 2- Amlodipine

Aim 2- Eplerenone

Aim 1- High Sodium

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AmlodipineExperimental Treatment1 Intervention

Amlodipine (dose 10 mg, once daily)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amlodipine

2004

Completed Phase 4

~40680

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Conn Syndrome, or primary aldosteronism, is treated by reducing aldosterone production or blocking its effects. Common treatments include mineralocorticoid receptor antagonists like spironolactone and eplerenone, which block aldosterone's action, reducing sodium retention and potassium loss. Calcium channel antagonists, such as verapamil, inhibit calcium channels in the adrenal gland's zona glomerulosa, reducing aldosterone synthesis. This approach is crucial for Conn Syndrome patients as it targets the root cause, improving blood pressure control and electrolyte balance.

Hemodynamic responses to verapamil monotherapy in patients with renal disease.Calcium antagonists and stimulus-secretion coupling of aldosterone.Tolvaptan for Primary Aldosteronism and Autosomal Dominant Polycystic Kidney Disease: A Case Report.