Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism (FAVOR)

Shanghai Jiao Tong University School of Medicine

Status and phase: Not yet enrolling; Phase 4

Conditions: Primary Aldosteronism

Treatments: Drug: Spironolactone; Drug: Finerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT06164379

FAVOR

Details and patient eligibility

About

To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism

Full description

1. Study design: This is a multi-center, double-blind, randomized, non-inferiority trial of finerenone vs. spironolactone in hypertensive patients with primary aldosteronism (PA). All patients will be randomized into finerenone group (Intervention group) and spironolactone group (Control group).
2. Objective: To compare the antihypertensive effects and Correction of hypokalemia in patients with PA.
3. Medicine: Finerenone (10mg tablet) and the matching placebo; Spironolactone (20mg tablet) and the matching placebo.
4. Study population: Men or women aged from18 years to 75 years old, with history of hypertension, Clinic DBP <110 mmHg, SBP <180 mmHg without any antihypertensive drugs for 2 weeks, were diagnosed PA and confirmed by captopril inhibition test or Saline infusion test. At the end of induction, Serum potassium level ≥ 3 mmol/L but less than 5 mmol/L.
5. Randomized and treatment: The initial dose of finerenone group is 10mg and spironolactone group is 20mg, respectively (week 0). For patients not meeting clinic blood pressure < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone or spironolactone should be increased one tablet at every visit (week 2, week 4). The whole treatment period was 8 weeks.
6. Follow up: After the induction period of two weeks and meeting the inclusion criteria, the patients with primary aldosteronism were randomized in an equal ratio to receive finerenone 10mg once daily. Patients received the initial dose (10mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of finernone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone would be increased to 20mg once daily for the second 2 weeks later (week 2) and 30 mg 4 weeks later (week 4), respectively. The whole treatment period was 8 weeks. if blood pressure > 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added. At every visit, the clinic and ambulatory blood pressure will be measured. The levels of serum potassium, creatinine, renin, aldosterone will be examined. The urinary microalbumin creatinine ratio will be also examined.
7. Organization: The Centre for Epidemiological Studies and Clinical Trials, Department of Hypertension, Ruijin Hospital, Shanghai, China.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 18-75 years old.
2. History of hypertension, Clinic DBP <110 mmHg, SBP <180 mmHg without any antihypertensive drugs for 2 weeks.
3. Primary Aldosteronism diagnosed and confirmed by captopril inhibition test or Saline infusion test.
4. At the end of induction, Serum potassium level ≥ 3 mmol/L but less than 5 mmol/L.
5. Signed the informed consent

Exclusion criteria

1. Other kinds of secondary hypertension
2. Obesity with BMI>30kg/m²（BMI= kg/㎡）
3. Serum potassium > 5.5 mmol/L
4. Serious hypertension（msSBP≥180mmHg, and/or msDBP≥110mmHg）
5. Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR < 25 ml/(min * 1.73㎡);
6. Abnormal liver function: ALT and AST ≥ 2 × ULN；
7. Cardiac insufficiency, acute myocardial infarction, stroke or other acute cardiovascular events within 6 months;
8. Take spironolactone, guanethidine or reserpine 30 days before enrollment;
9. Known or suspected tumor; Other autoimmune diseases, uncontrolled infectious diseases, serious respiratory, blood and nervous system diseases;
10. There is a pregnancy plan in pregnancy or 3 months before and after treatment. Breast-feeding women;
11. Those who have mental illness, alcohol or drug abuse and cannot cooperate with treatment.
12. Be allergic to the study drugs
13. Without Signed the informed consent
14. Anticipating another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Finerenone group

Experimental group

Description:

After the induction period of two weeks, the patients with primary aldosteronism were randomized in an equal ratio to receive finerenone 10mg once daily. Patients received the initial dose (10mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of finerenone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP \< 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone would be increased to 20mg once daily for the second 2 weeks later (week 2) and 30 mg 4 weeks later (week 4), respectively. The whole treatment period was 8 weeks. if blood pressure \> 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added.

Treatment:

Drug: Finerenone

Spironolactone group

Active Comparator group

Description:

After the induction period of two weeks, the patients with primary aldosteronism were randomized in an equal ratio to receive spironolactone 20mg once daily. Patients received the initial dose (20mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of spironolactone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP \< 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finernone would be increased to 40mg once daily for the second 2 weeks later (week 2) and 60 mg 4 weeks later (week 4), respectively. the whole treatment period was 8 weeks. if blood pressure \> 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added.

Treatment:

Drug: Spironolactone