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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    60
  • sponsor
    Third Military Medical University
Updated on 24 January 2021
hypertension
heart failure
electrolytes
aldosterone
potassium
spironolactone
angiotensin
renin
endothelial dysfunction
hyperplasia
hyperaldosteronism
captopril
congenital adrenal hyperplasia
resistant hypertension
aldosteronoma
chemical ablation
bilateral adrenal hyperplasia
computed tomography of adrenals

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.

Details
Condition Vascular Diseases, Vascular Diseases, Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Diabetes and Hypertension, Hyperaldosteronism, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, primary hyperaldosteronism, primary aldosteronism, conn, high blood pressure, arterial hypertension
Treatment Endovascular chemical Ablation of Adrenal Gland
Clinical Study IdentifierNCT04409431
SponsorThird Military Medical University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Primary Aldosteronis diagnosed by increased Renin ratio (ARR) and serum aldosterone levels 15 ng / dl, and confirmed by saline injection test or captopril inhibition test
Idiopathic aldosteronism, bilateral adrenal hyperplasia, and unilateral adrenal hyperplasia with no superior secretion confirmed with adrenal CT and adrenal venous blood (AVS)
The patients was diagnosed with aldosteronoma or unilateral adrenal hyperplasia but refused to surgical excision
Signed informed consent and agreed to participate in this study

Exclusion Criteria

Aldosterone cancer
Hyperkalemia
Renal failure or the following history of nephropathy: serum creatinine 1.5 times higher than the upper limit; dialysis history; or nephrotic syndrome
Secondary hypertension except the primary aldosteronism
Adrenergic insufficiency
Heart failure with NYHA grade - grade or unstable angina, severe cardiovascular and cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke and other acute cardiovascular events
Acute infections, tumors and severe arrhythmias, psychiatric disorders, drugs or alcohol addicts
Liver dysfunction or the following history of liver disease: AST or ALT 2 times higher than the upper limit, liver cirrhosis, history of hepatic encephalopathy, esophageal variceal history or portal shunt history
Coagulation dysfunction
Pregnant women or lactating women
Participated in other clinical trials or admitted with other research drugs within 3 months prior to the trial
Any surgical or medical condition which can significantly alter the absorption, distribution, metabolism, or excretion of any study drug
Allergy or any contraindications for the study drugs, contrast agents and alcohol
Refused to sign informed consent
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