Clinical trial NCT05924620: Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism
Official title: Efficacy and Safety of Finerenone in Patients With Primary Aldosteronism: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Aldosteronism
Keywords: finerenone
spironolactone
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the change of daytime mean systolic blood pressure in the overall cohort between two groups.
timeFrame: At baseline and 2 month of follow-up
Secondary outcomes:
measure: Compare the serum potassium elevation in the overall cohort between two groups.
timeFrame: At baseline and 2 month of follow-up
measure: Compare the change of daytime mean diastolic blood pressure in the overall cohort between two groups.
timeFrame: At baseline and 2 month of follow-up
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affilated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: the Chongqing Primary Aldosteronism Study (CONPASS) Group
name: Qifu Q Li, PhD
role: STUDY_CHAIR
References: