Primary AldosteronismNCT07137364
Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism
An observational study of Primary Aldosteronism and Hypertension, run by Third Military Medical University at 1 site in China.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Primary Aldosteronism, Hypertension
- What is being tested?
- spironolactone
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 30 Apr 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese
Who may be able to join
- Male or female, aged 30~65 years.
- PA patients with positive screening tests and saline suppression tests, and with AVS to determine lateralization. These patients have hypertension defined as office blood pressure ≥ 140/90 mmHg, or 24-hour ambulatory blood pressure showing average ≥ 130/80 mmHg, daytime blood pressure ≥ 135/85 mmHg, or nighttime blood pressure ≥ 120/70 mmHg.
- Patients with unilateral aldosterone-producing adenoma who decline surgery, or patients with non-adenoma, unilateral PA confirmed by AVS and meeting the above PA-related hypertension criteria.
- Provision of written informed consent to participate in the study.
Who cannot join
- Hyperkalemia.
- Renal impairment or have history of renal disease: serum creatinine > 1.5 × upper limit of normal (ULN), dialysis, or nephrotic syndrome.
- Other confirmed secondary hypertension: pheochromocytoma, Cushing's syndrome, thyroid disorders, parathyroid disorders, acromegaly, renovascular disease, aortic disorders, chronic alcoholism, or drug dependence, etc.
- Adrenal insufficiency.
- Heart failure with NYHA class II-IV or stroke.
- Acute infection, malignancy, severe arrhythmia, psychiatric disorders, or drug/alcohol abuse.
Show all 11Show fewer
- Significant hepatic dysfunction or have history of liver disease: AST or ALT > 2 × ULN, cirrhosis, hepatic encephalopathy, esophageal varices or portosystemic shunt.
- Pregnancy or lactation.
- Participation in another clinical trial within the past 3 months.
- Inability to complete follow-up.
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Daping Hospital, Army Medical Center of PLA
Chongqing, Chongqing Municipality, 400042
Zhiming Zhu, MD, +8613608313322, hbpcms@sina.com
About this study
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:
- What is the long-term effect of spironolactone treatment for lateralized PA?
- What is the optimal dose of spironolactone treatment for the relief of renin inhibition in patients with lateralized PA? Participants will receive spironolactone treatment as part of their regular medical care for more than 12 months, and their clinical indicators, including blood pressure, biochemical remission, cardiovascular and renal damage, and the incidence of cardiovascular and cerebrovascular events, will be analyzed.
Read the detailed description
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.
- Conditions
- Primary Aldosteronism, Hypertension
- Being tested
- spironolactone
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactoneDrug
Also called Aldactone
The patients receive spironolactone treatment based on their conditions
| Study group | Role | What they receive |
|---|---|---|
| Unilateral primary aldosteronism group | The patients are diagnosed with unilateral primary aldosteronism based on adrenal venous sampling diagnosis, they will treated with spironolactone according to their own condition Receives: Drug: spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to spironolactone treatment at 12 months.
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to spironolactone treatment at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 May 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
- Investigators
- Zhiming Zhu, MD, Study chair, Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137364
- Sponsor's protocol ID
- SPIRO in PA
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07137364
- Acronym / sponsor ID
- SPIRO in PA
- Conditions
- Primary Aldosteronism, Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the long-term effect of spironolactone treatment for lateralized PA?
- What is the optimal dose of spironolactone treatment for the relief of renin inhibition in patients with lateralized PA? Participants will receive spironolactone treatment as part of their regular medical care for more than 12 months, and their clinical indicators, including blood pressure, biochemical remission, cardiovascular and renal damage, and the incidence of cardiovascular and cerebrovascular events, will be analyzed.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unilateral primary aldosteronism group | – | Drug: spironolactoneThe patients are diagnosed with unilateral primary aldosteronism based on adrenal venous sampling diagnosis, they will treated with spironolactone according to their own condition |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese
Key inclusion criteria (4 listed)
- Male or female, aged 30~65 years.
- PA patients with positive screening tests and saline suppression tests, and with AVS to determine lateralization. These patients have hypertension defined as office blood pressure ≥ 140/90 mmHg, or 24-hour ambulatory blood pressure showing average ≥ 130/80 mmHg, daytime blood pressure ≥ 135/85 mmHg, or nighttime blood pressure ≥ 120/70 mmHg.
- Patients with unilateral aldosterone-producing adenoma who decline surgery, or patients with non-adenoma, unilateral PA confirmed by AVS and meeting the above PA-related hypertension criteria.
- Provision of written informed consent to participate in the study.
Key exclusion criteria (11 listed)
- Hyperkalemia.
- Renal impairment or have history of renal disease: serum creatinine > 1.5 × upper limit of normal (ULN), dialysis, or nephrotic syndrome.
- Other confirmed secondary hypertension: pheochromocytoma, Cushing's syndrome, thyroid disorders, parathyroid disorders, acromegaly, renovascular disease, aortic disorders, chronic alcoholism, or drug dependence, etc.
- Adrenal insufficiency.
- Heart failure with NYHA class II-IV or stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spironolactoneAlso: AldactoneThe patients receive spironolactone treatment based on their conditions | Drug | Unilateral primary aldosteronism group |
Primary outcome
Change of systolic blood pressure
Time frame: From enrollment to spironolactone treatment at 12 months.
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.
Change of diastolic blood pressure
Time frame: From enrollment to spironolactone treatment at 12 months.
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.
16 secondary outcomes
Change of anti-hypertensive regimen
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of serum potassium
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of plasma aldosterone
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of plasma renin
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of fasting plasma glucose
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum total cholesterol
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum triglyceride
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum high-density lipoprotein cholesterol
Time frame: From enrollment to spironolactone treatment at 12 months.
Changes of serum low-density lipoprotein cholesterol
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of serum creatinine
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of 24-hour urine microalbumin
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of estimated glomerular filtration rate
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of urine albumin-to-creatinine ratio
Time frame: From enrollment to spironolactone treatment at 12 months.
Change of urine aldosterone
Time frame: From enrollment to spironolactone treatment at 12 months.
Incidence of cardiovascular events
Time frame: From enrollment to spironolactone treatment at 12 months.
Numbers of adverse reactions
Time frame: From enrollment to spironolactone treatment at 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiming Zhu, MD study chair
Department of Hypertension and Endocrinology, Daping Hospital, Army Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Hypertension, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhencheng Yan, MD (+8613983656682, zhenchengyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of systolic blood pressure (time frame: From enrollment to spironolactone treatment at 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.