NCT03398785

Adrenal Artery Ablation Treats Primary Aldosteronism

Completed Phase 3 Last updated 8 July 2019

What this trial tests

Phase 3 trial testing Endovascular chemical Ablation of Adrenal Gland in Primary Aldosteronism in 66 participants. Completed in 30 June 2019.

Timeline

1 October 2017

Primary endpoint
31 December 2018

30 June 2019

Quick facts

Lead sponsor	Third Military Medical University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	1 October 2017
Primary completion	31 December 2018
Estimated completion	30 June 2019
Sites	1 location across China

Drugs / interventions tested

• Endovascular chemical Ablation of Adrenal Gland

Conditions studied

• Primary Aldosteronism — all drugs for Primary Aldosteronism →
• Hypertension — all drugs for Hypertension →

Sponsor

Third Military Medical University

Who can join

Adults 30 to 60, any sex, with Primary Aldosteronism or Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary aldosteronism (PA) is one of the most common cause of endocrine and resistant hypertension. Current studies have shown that the activation of the renin-angiotensin-aldosterone system (RAAS) and the increased sympathetic nerve activity in the central or local tissue are the key mechanisms of high blood pressure and its organ damages.

The classical method for diagnosis of primary aldosteronism depends on the detection of peripheral venous blood aldosterone level, which is incapable of accurate positioning diagnosis. On the other hand, the current guidelines recommend that surgery and aldosterone receptor inhibitors were the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small part of unilateral adrenal hyperplasia can be treated by surgery. More than 60% of idiopathic aldosteronism and bilateral adrenal hyperplasia need long-term drug therapy. However, long-term aldosterone inhibitor treatment may also cause hyperkalemia, male breast hyperplasia, female hirsutism and other adverse reactions.

Therefore, the investigators proposed that endovascular chemical partial ablation of the adrenal gland can lower the aldosterone level, reduce the blood pressure and recover the potassium metabolism balance. In order to confirm the above effects, the investigators conduct an open, prospective, positive controlled study in patients with primary aldosteronism patients (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). The effects on blood pressure, blood electrolytes, adrenal hormones, metabolic indexes, target organ damages were observed to explore the efficacy and safety of the endovascular ablation of the adrenal gland in the treatment of primary aldosteronism.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Determination of adrenal hypersecretion in primary Aldosteronism without aldosterone-production adenomas.
   Sun F, Hong Y, Zhang H, Liu X, et al · · 2021 · cited 6× · PMID 34059026 · DOI 10.1186/s12902-021-00770-1