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Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism

NCT04409431 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-20

No results posted yet for this study

Summary

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.

Current guidelines suggest that surgery and aldosterone receptor inhibitors are the only treatment for primary aldosteronism. However, only about 35% of aldosterone tumors and a small number of unilateral adrenal hyperplasia can be treated surgically. More than 60% of primary aldosteronism and bilateral adrenal hyperplasia need long-term oral aldosterone receptor inhibitors. At present, spironolactone is the most commonly used aldosterone receptor inhibitor. Long term use of spironolactone may cause hyperkalemia, hyperplasia of male mammary gland, hairiness of female and other adverse reactions. Therefore, the researchers suggest that partial removal of adrenals can reduce aldosterone level, lower blood pressure and restore potassium metabolism balance.

In patients with primary hyperaldosteronism, the level of aldosterone increases, which can cause vascular endothelial dysfunction, myocardial injury and ventricular fibrosis. The study shows that long-term oral administration of spironolactone can reverse the above cardiovascular damage and correct heart failure. Adrenal artery ablation can reduce aldosterone level, but the long-term effect on cardiovascular system is unknown. In order to confirm the effect of adrenal artery ablation on blood pressure and cardiovascular system, the researchers conducted an open cohort study on patients with primary aldosteronism (including aldosterone, idiopathic aldosteronism and adrenal hyperplasia). To observe the effect of adrenal artery ablation and spironolactone on blood pressure, blood electrolyte, metabolic index, cardiovascular events and cardiovascular death risk in patients with primary aldosteronism, and to explore its efficacy and safety.

Conditions

Interventions

PROCEDURE

Endovascular chemical Ablation of Adrenal Gland

Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Principal Investigators

  • Zhu ZM, MD · The third militery medical university

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-12-30
Completion
2025-12-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409431 on ClinicalTrials.gov