Actively Recruiting
Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
Led by Third Military Medical University · Updated on 2024-08-20
60
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effects of Adrenal Artery Ablation and Spironolactone in Patients With Primary Aldosteronism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary aldosteronism by increased renin ratio and serum aldosterone ≥15 ng/dl, confirmed by saline injection or captopril test
- Have idiopathic aldosteronism, bilateral adrenal hyperplasia, or unilateral adrenal hyperplasia without superior secretion confirmed by adrenal CT and adrenal venous blood sampling
- Diagnosed with aldosteronoma or unilateral adrenal hyperplasia but declined surgical removal
- Signed informed consent and agreed to participate in the study
You will not qualify if you...
- Diagnosis of aldosterone cancer
- Presence of hyperkalemia
- Renal failure or history of nephropathy including serum creatinine 1.5 times above upper limit, dialysis, or nephrotic syndrome
- Secondary hypertension other than primary aldosteronism
- Adrenergic insufficiency
- Heart failure NYHA class I-III, unstable angina, severe cardiovascular or cerebrovascular stenosis, myocardial infarction, intracranial aneurysm, stroke, or other acute cardiovascular events
- Acute infections, tumors, severe arrhythmias, psychiatric disorders, or addiction to drugs or alcohol
- Liver dysfunction or history of liver disease including AST or ALT twice above upper limit, cirrhosis, hepatic encephalopathy, esophageal varices, or portal shunt
- Coagulation disorders
- Pregnant or breastfeeding women
- Participation in other clinical trials or use of research drugs within 3 months prior to this trial
- Any surgical or medical condition significantly affecting drug absorption, distribution, metabolism, or excretion
- Allergy or contraindications to study drugs, contrast agents, or alcohol
- Refusal to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
The third hospital affiliated to the Army Medical University
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
Research Team
L
Li Yingsha, MD
CONTACT
Z
Zhu ZM, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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