Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism
NCT ID: NCT06164379
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2023-12-16
2024-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Finerenone group
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.
Finerenone
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.
Spironolactone group
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.
Spironolactone
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.
Interventions
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Finerenone
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.
Spironolactone
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Ji-Guang Wang
Director of the Shanghai Institute of Hypertension, Director of the Department of Hypertension
Principal Investigators
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Jiguang Wang, MD. PhD
Role: STUDY_DIRECTOR
Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China
Locations
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Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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FAVOR
Identifier Type: -
Identifier Source: org_study_id