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

A Double-blind, Randomized Controlled Study of Finerenone vs. Spironolactone in Hypertensive Patients With Primary Aldosteronism

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

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Aldosteronism
• Intervention / Treatment: Drug: Finerenone; Drug: Spironolactone

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiguang Wang, MD. PhD; Phone Number: 610911 +86-2164370045; Email: jiguangw@163.com
• Study Contact Backup: Name: Yuanyuan Kang, MD. PhD; Phone Number: 610912 +86-2164370045; Email: kangyuanyuan@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of 24-hour ambulatory systolic blood pressure from the baseline level.	24-hour ambulatory systolic blood pressure	8 weeks
The proportion of patients with normal serum potassium level.	serum potassium level	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of clinic systolic and diastolic blood pressure from the baseline level.	clinic systolic and diastolic blood pressure	8 weeks
The change of other components of 24-hour ambulatory blood pressure from the baseline level.	other components of 24-hour ambulatory blood pressure	8 weeks
The changes of plasma renin and aldosterone from the baseline levels.	plasma renin and aldosterone	8 weeks
The change of urinary microalbumin creatinine ratio (ACR) from the baseline level.	urinary microalbumin creatinine ratio	8 weeks
The change of estimate glomerular filtration rate from the baseline level.	estimate glomerular filtration rate	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.	gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia	8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Director: Jiguang Wang, MD. PhD, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2023
• Primary Completion (Estimated): December 16, 2024
• Study Completion (Estimated): December 16, 2024

Study Registration Dates

• First Submitted: December 2, 2023
• First Submitted That Met QC Criteria: December 2, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Spironolactone; Primary Aldosteronism; Finerenone
• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Spironolactone
• Other Study ID Numbers: FAVOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No