Primary Aldosteronism
Conditions
Keywords
finerenone, spironolactone
Brief summary
To study the efficacy and safety of finerenone in patients with primary aldosteronism
Detailed description
This is a prospective and randomized study involving patients with primary aldosteronism(PA). All paticipants will be randomized into finerenone group(Intervention group) and spironolactone group(Control group) and to compare the antihypertensive effect in patients with PA. If the self-measured blood pressure of patients at home continues to be greater than 140/90 mmHg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.
Interventions
DRUGfinerenone
Patients with PA divided into Intervention group need to take finerenone for 60 days (20mg qd).
Sponsors
Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients who meet the following criterion can be included in this study. 1. Patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up. 2. Patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required. 3. Aged between 18-70, male or female, with legal capacity. 4. eGFR≥60(ml/min/1.73 m2) 5. Patients with PA and substandard blood pressure (≥140/90mmHg) who didn't take any antihypertensive drugs or who had been using antihypertensive drugs other than MRA steadily for 2 weeks or more
Exclusion criteria
Patients with one of the following conditions will be excluded in this study: 1. To assess patients with poor compliance who had difficulty fully participating in the study, or who refused to sign written informed consent for the study 2. Patients with heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal, estimated glomerulus filtration rate\<30ml/min/m2 3. Patients with serum potassium \> 5.0mmol/L without potassium supplementation 4. Patients with stroke or acute coronary syndrome within 3 months 5. Pregnant or lactating women 6. Patients currently receiving sex hormone or glucocorticoid therapy 7. Patients with a history of uncontrolled malignant tumor 8. Patients who took MRA within 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups. | At baseline and 2 month of follow-up | Measured by ambulatory blood pressure monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the serum potassium elevation in the overall cohort between two groups. | At baseline and 2 month of follow-up | Measured by blood electrolytes |
| Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups. | At baseline and 2 month of follow-up | Measured by ambulatory blood pressure monitoring |
Countries
China
Outcome results
None listed