Comparing two treatments for primary aldosteronism
The First Affiliated Hospital of Xinjiang Medical University
This study is testing whether surgery or a less invasive procedure works better and is safer for people with primary aldosteronism to help manage their high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 570 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Xinjiang Medical University Academic / other |
| Locations | 1 site (Ürümqi, Xinjiang) |
| Trial ID | NCT06513585 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of adrenalectomy versus superselective adrenal artery embolization in patients diagnosed with primary aldosteronism. It is a prospective, multicenter, randomized controlled trial designed to evaluate these two interventional therapies as alternatives for treating this condition. Primary aldosteronism is a significant cause of secondary hypertension, and the study seeks to provide insights into the best treatment options available. The research will involve patients aged 18 to 60 who meet specific diagnostic criteria for the condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-60 diagnosed with unilateral primary aldosteronism.
Not a fit: Patients with severe liver disease, renal insufficiency, or other forms of secondary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from primary aldosteronism.
How similar studies have performed: Other studies have explored similar treatment approaches, but this specific comparison of embolization versus adrenalectomy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-60 * Diagnosed with primary aldosteronism according to the 2016 Clinical guidelines of the International Endocrine Society * Primary aldosteronism diagnosed according to international guidelines Unilateral disease by AVS or PET-CT criteria * Patients and their family members signed informed consent and agreed to participate in the study Exclusion Criteria: * A history of severe hypersensitivity to contrast media * Severe liver disease complications, such as thrombocytopenia, esophageal varices rupture bleeding, etc * Renal insufficiency (serum creatinine \> 176mmol/L or estimated glomerular filtration rate \< min.1.73m2) * Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogen, herbal medicines containing glycyrrhizin), pregnancy hypertension and other secondary hypertension * Combined with genetic diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesia (Gitelman syndrome) * Stroke, myocardial infarction and stent implantation occurred in the past 3 months * Serious other diseases, such as heart dysfunction (grade IV), acute infections, autoimmune diseases, various malignant tumors, etc * Participated in other clinical trials within the past 3 months * Pregnant, breastfeeding, or planning a pregnancy * Identify patients with alcohol allergy
Where this trial is running
Ürümqi, Xinjiang
- The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
Study contacts
- Study coordinator: Xiang Xie, PhD
- Email: xiangxie999@sina.com
- Phone: +869914366892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.