Hypertension, Mineralocorticoid Receptor Antagonist, Primary Aldosteronism, Statin
Conditions
Keywords
primary aldosteronism, hypertension, Statin
Brief summary
The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.
Interventions
DRUGSimvastatin combined with Amlodipine besylate
6-month treatment of Simvastatin combined with Amlodipine besylate
DRUGSimvastatin combined with Spironolactone and Amlodipine besylate.
6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate.
DRUGAmlodipine besylate combined Spironolactone
6-month treatment of Amlodipine besylate combined with Spironolactone
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of primary aldosteronism
Exclusion criteria
* Allergy to drugs in this study * Pregnancy * Severe liver and kidney dysfunction * Mental illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in plasma aldosterone levels | 6 month | blood samples are collected at baseline and 6 months after treatment to measure plasma aldosterone levels， and compare between groups and within groups (pg/ml) |
| changes in 24-hour urinary aldosterone levels | 6 month | 24 hours urine are collected at baseline and 6 months after treatment to measure 24-hour urinary aldosterone， and compare between groups and within groups(pmol/24h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in serum renin level | 6 month | blood samples are collected at baseline and 6 months after treatment to measure serum renin levels, and compare between groups and within groups (mU/L) |
| changes in office blood pressure and home blood pressure | 6 month | Record office blood pressure at baseline and at follow-up after medical treatment (mmHg), and compare between groups and within groups |
| changes in blood glucose | 6 month | blood samples are collected at baseline and 6 months after treatment to measure blood glucose， and compare between groups and within groups (mmol/L) |
| changes in plasma cholesterol levels | 6 month | blood samples are collected at baseline and 6 months after treatment to measure plasma cholesterol levels， and compare between groups and within groups (mmol/L) |
| changes in serum potassium levels | 6 month | blood samples are collected at baseline and 6 months after treatment to measure serum potassium levels， and compare between groups and within groups (mmol/L) |
Countries
China
Contacts
Primary Contactsun fang
Outcome results
None listed