An observational study in Primary Aldosteronism and Hypertension, sponsored by Yahao Zhang. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Yahao Zhang · Observational
This study is a retrospective review that compared two different techniques for a diagnostic procedure called adrenal vein sampling (AVS) in patients with a hormone condition known as primary aldosteronism. AVS is used to determine if one or both adrenal glands are overproducing a hormone called aldosterone, which causes high blood pressure.
The two techniques compared were "simultaneous" AVS (taking blood samples from both adrenal veins at the same time) and "sequential" AVS (taking blood samples from one adrenal vein and then the other). The goal was to evaluate both techniques for identifying the source of the hormone problem and to compare their safety and efficiency.
The study retrospectively reviewed the medical records of 238 patients who underwent AVS without using a stimulating drug (ACTH). The study assessed catheter placement success, diagnostic concordance between the two methods, fluoroscopy time, radiation dose, and procedure-related complications.
This was a multicenter, retrospective cohort study conducted to systematically evaluate the procedural efficacy, diagnostic concordance, and safety profiles of sequential versus simultaneous adrenal vein sampling (AVS) without adrenocorticotropic hormone (ACTH) stimulation in patients with primary aldosteronism (PA).
A total of 238 consecutive patients with confirmed PA who underwent AVS between September 2022 and December 2024 at Fuwai Hospital (Chinese Academy of Medical Sciences) and The First Affiliated Hospital of University of Science and Technology of China were enrolled. Patients were categorized into two groups based on the AVS technique used: 137 patients underwent sequential AVS and 101 underwent simultaneous AVS. All procedures were performed without pharmacologic stimulation with ACTH.
The endpoints assessed included:
Statistical analyses, including multivariable logistic regression and linear regression models, were employed to compare outcomes between the two groups while adjusting for potential confounding factors such as age, gender, body mass index, and lipid profiles.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's enrollment of 238 is above the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →This is the only study on the registry with Yahao Zhang as lead sponsor.
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The study population consisted of 238 consecutive adults with confirmed primary aldosteronism who underwent unstimulated adrenal vein sampling at two tertiary medical centers in China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Underwent adrenal vein sampling (AVS) between September 2022 and December 2024 at one of the participating centers.
AVS was performed without adrenocorticotropic hormone (ACTH) stimulation.
Exclusion Criteria:
Confirmed or suspected ectopic ACTH secretion, primary adrenal insufficiency, or other forms of mineralocorticoid excess.
Severe renal impairment (e.g., estimated \< 30 mL/min/1.73 m²).
Active (excluding non-melanoma skin cancer) within 5 years.
class C hepatic impairment.
Individuals with incomplete procedural, laboratory, or follow-up data essential for endpoint analysis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this cohort underwent sequential adrenal vein sampling (AVS) without ACTH stimulation. This procedure involved the selective catheterization of one adrenal vein for blood collection, followed by catheter exchange and subsequent cannulation of the contralateral adrenal vein for sampling. All procedures were performed via right median cubital or femoral venous access. Successful catheterization was confirmed by a selectivity index (adrenal vein/inferior vena cava cortisol ratio) of ≥2.
Patients in this cohort underwent simultaneous bilateral adrenal vein sampling (AVS) without ACTH stimulation. This procedure involved the concurrent selective catheterization of both adrenal veins and near-simultaneous blood collection from both sides, along with a reference sample from the inferior vena cava. Venous access was established via both the right median cubital and femoral veins. Successful catheterization was confirmed by a selectivity index (adrenal vein/inferior vena cava cortisol ratio) of ≥2.
Cannulation Success Rate
The success rate of selective catheterization of the adrenal veins, confirmed by a selectivity index (adrenal vein cortisol / inferior vena cava cortisol) of ≥2. Assessed separately for the left adrenal vein, right adrenal vein, and bilaterally.
Time frame: At the time of the adrenal vein sampling procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Lateralization Pattern
The pattern of aldosterone hypersecretion as determined by the lateralization index (LI). LI is calculated as the ratio of the higher to the lower aldosterone-to-cortisol ratio between the two adrenal veins. Lateralization is defined as LI ≥2. Patterns are categorized as no lateralization, left lateralization, or right lateralization.
Time frame: At the time of the adrenal vein sampling procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Aldosterone Concentration
Plasma aldosterone concentration measured in ng/dL from the left adrenal vein, right adrenal vein, and inferior vena cava. Concentrations will be reported separately for each sampling site.
Time frame: At the time of the adrenal vein sampling procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Cortisol Concentration
Plasma cortisol concentration measured in nmol/L from the left adrenal vein, right adrenal vein, and inferior vena cava. Concentrations will be reported separately for each sampling site.
Time frame: At the time of the adrenal vein sampling procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Normalized Aldosterone Ratio
The aldosterone-to-cortisol ratio for each adrenal vein, calculated using aldosterone and cortisol concentrations converted to consistent units. The ratio is unitless and will be reported separately for the left and right adrenal veins.
Time frame: At the time of the adrenal vein sampling procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Fluoroscopy Time
The total duration of fluoroscopy guidance used during the adrenal vein sampling procedure, measured in minutes.
Time frame: At the time of the adrenal vein sampling procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Radiation Dose
The total radiation dose administered to the patient during the adrenal vein sampling procedure, measured in milligray (mGy).
Time frame: At the time of the adrenal vein sampling procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Procedure-related Complications
The incidence of procedure-related adverse events, including but not limited to adrenal vein hematoma, vascular spasm, and catheter entanglement.
Time frame: From the start of the adrenal vein sampling procedure up to 24 hours post-procedure (data collected retrospectively for participants enrolled between September 2022 and December 2024)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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