An observational study in Primary Aldosteronism and Hypertension, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Third Military Medical University · Observational
The goal of this observational study is to learn about the optimal dose of spironolactone treatment and the long-term outcomes on cardiovascular and cerebrovascular events in patients with lateralized PA who are unwilling to undergo surgery. The main question it aims to answer is:
Primary aldosteronism (PA) is one of the most common causes of endocrine and treatment-resistant hypertension. Current guidelines suggest that surgery and aldosterone receptor antagonists (MRAs), such as spironolactone, are the main treatment for PA. Patients with aldosterone-producing adenoma who decline surgery, as well as those with idiopathic hyperaldosteronism, are usually treated with spironolactone. However, there is a lack of large-scale, long-term, prospective, randomized controlled trials on spironolactone. In a retrospective cohort of 602 PA patients treated with long-term spironolactone therapy, Hundemer et al. found that the 10-year risk of major cardiovascular events and all-cause mortality was increased, compared with that in patients with essential hypertension. In contrast, PA patients who underwent adrenalectomy had a lower risk of cardiorenal vascular events than that in the spironolactone-treated patients, which was comparable to that of patients with essential hypertension. Further analysis revealed that if PA patients remained in a low-renin state after drug therapy, their risk of myocardial infarction, stroke, and heart-failure hospitalization was almost three-fold higher than that in patients with essential hypertension. Therefore, high doses of spironolactone (60\~100 mg/d) were recommended to relieve renin suppression. However, prolonged high-dose spironolactone is associated with numerous side effects, including hyperkalaemia, gynaecomastia and sexual dysfunction in men, menstrual irregularities in women, and central-nervous-system symptoms. Moreover, MRAs only block the effect of aldosterone at the receptor level, failing to suppress aldosterone synthesis. In addition, aldosterone exhibits receptor-independent actions. Consequently, whether spironolactone mitigates aldosterone-mediated cardiovascular and cerebrovascular events remains uncertain, and the optimal dose with fewer adverse effects needs to be defined. To clarify the optimal dose of spironolactone treatment and the long-term outcomes on cardiovascular and cerebrovascular events, the researchers conducted a long-term study involving patients with lateralized PA who are unwilling to undergo surgery. When the blood pressure fails to meet the criteria, antihypertensive drugs such as amlodipine and irbesartan, are combined. the PA patients will be confirmed as unilateral PA based on the results of adrenal venous sampling and different doses of spironolactone. The PA patients will take spironolactone treatment as part of their regular medical care for more than 12 months. The blood pressures, biochemical remission, cardiovascular and renal damage, and cardiovascular and cerebrovascular events will be analyzed after the spironolactone treatment. The antihypertensive efficacy and adverse reactions will be studied.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 350 is above the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
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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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients are diagnosed with unilateral primary aldosteronism based on adrenal venous sampling diagnosis, they will treated with spironolactone according to their own condition
Drug: spironolactone
The patients receive spironolactone treatment based on their conditions
Also known as: Aldactone
Change of systolic blood pressure
This study will gain insight into the effect of spironolactone treatment on systolic blood pressure. The systolic blood pressure (mmHg) is measured before and after spironolactone treatment, respectively. The changes of systolic blood pressure are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of diastolic blood pressure
This study will gain insight into the effect of spironolactone treatment on diastolic blood pressure. The diastolic blood pressure (mmHg) is measured before and after spironolactone treatment, respectively. The changes of diastolic blood pressure are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of anti-hypertensive regimen
This study will gain insight into the effect of spironolactone treatment on anti-hypertensive regimen. The anti-hypertensive regimens are measured before and after spironolactone treatment, respectively. The changes of anti-hypertensive regimens are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of serum potassium
This study will gain insight into the effect of spironolactone treatment on serum potassium. The concentrations of serum potassium (mmol/L) are measured before and after spironolactone treatment, respectively. The changes of serum potassium are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of plasma aldosterone
This study will gain insight into the effect of spironolactone treatment on plasma aldosterone. The concentrations of plasma aldosterone (ng/dL) are measured before and after spironolactone treatment, respectively. The changes of plasma aldosterone are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of plasma renin
This study will gain insight into the effect of spironolactone treatment on plasma renin. The concentrations of plasma renin (mU/L) are measured before and after spironolactone treatment, respectively. The changes of plasma renin are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of fasting plasma glucose
This study will gain insight into the effect of spironolactone treatment on fasting plasma glucose. The concentrations of fasting plasma glucose (mmol/L) are measured before and after spironolactone treatment, respectively. The changes of fasting plasma glucose are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum total cholesterol
This study will gain insight into the effect of spironolactone treatment on serum total cholesterol. The concentrations of serum total cholesterol (mmol/L) are measured before and after spironolactone treatment, respectively. The changes of serum total cholesterol are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum triglyceride
This study will gain insight into the effect of spironolactone treatment on serum triglyceride. The concentrations of serum triglyceride (mmol/L) are measured before and after spironolactone treatment, respectively. The changes of serum triglyceride are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum high-density lipoprotein cholesterol
This study will gain insight into the effect of spironolactone treatment on serum high-density lipoprotein cholesterol. The concentrations of serum high-density lipoprotein cholesterol (mmol/L) are measured before and after spironolactone treatment, respectively. The changes of serum high-density lipoprotein cholesterol are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum low-density lipoprotein cholesterol
This study will gain insight into the effect of spironolactone treatment on serum low-density lipoprotein cholesterol. The concentrations of serum low-density lipoprotein cholesterol (mmol/L) are measured before and after spironolactone treatment, respectively. The changes of serum low-density lipoprotein cholesterol are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of serum creatinine
This study will gain insight into the effect of spironolactone treatment on serum creatinine. The concentrations of serum creatinine (µmol/L) are measured before and after spironolactone treatment, respectively. The changes of serum creatinine are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of 24-hour urine microalbumin
This study will gain insight into the effect of spironolactone treatment on 24-hour urine microalbumin. The concentrations of 24-hour urine microalbumin (mg) are measured before and after spironolactone treatment, respectively. The changes of 24-hour urine microalbumin are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of estimated glomerular filtration rate
This study will gain insight into the effect of spironolactone treatment on estimated glomerular filtration rate. The variables of estimated glomerular filtration rate (ml/min/1.73m²) are measured before and after spironolactone treatment, respectively. The changes of estimated glomerular filtration rate are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of urine albumin-to-creatinine ratio
This study will gain insight into the effect of spironolactone treatment on urine albumin-to-creatinine ratio. The variables of urine albumin-to-creatinine ratio (mg/g) are measured before and after spironolactone treatment, respectively. The changes of urine albumin-to-creatinine ratio are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of urine aldosterone
This study will gain insight into the effect of spironolactone treatment on urine aldosterone. The concentrations of urine aldosterone (ng/dL) are measured before and after spironolactone treatment, respectively. The changes of urine aldosterone are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Incidence of cardiovascular events
This study will gain insight into the effect of spironolactone treatment on cardiovascular events (%). The cardiovascular events include coronary heart disease, stroke, peripheral artery disease, etc. Incidence of cardiovascular events are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Numbers of adverse reactions
This study will evaluate the adverse effects of spironolactone treatment. The adverse reactions include itchy skin, tiredness, headache, etc. Numbers of adverse reactions are analyzed after the spironolactone treatment.
Time frame: From enrollment to spironolactone treatment at 12 months.
Plan to share: No
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Third Military Medical University