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

NCT06164379 | Unknown Phase 4 DMC

• 1 other identifier: FAVOR
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Aldosteronism

Keywords

Primary Aldosteronism; Spironolactone; Finerenone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• The change of clinic systolic and diastolic blood pressure from the baseline level.

  8 weeks

• The change of other components of 24-hour ambulatory blood pressure from the baseline level.

  8 weeks

• The changes of plasma renin and aldosterone from the baseline levels.

  8 weeks

• The change of urinary microalbumin creatinine ratio (ACR) from the baseline level.

  8 weeks

• The change of estimate glomerular filtration rate from the baseline level.

  8 weeks

Other Outcomes (1)

• Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events.

  8 weeks

Study Arms (2)

Finerenone group

EXPERIMENTAL

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

Spironolactone group

ACTIVE COMPARATOR

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

Interventions

Finerenone DRUG

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.

Finerenone group

Spironolactone DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years old.
• History of hypertension, Clinic DBP \<110 mmHg, SBP \<180 mmHg without any antihypertensive drugs for 2 weeks.
• Primary Aldosteronism diagnosed 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.
• Signed the informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

finerenone; Spironolactone

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jiguang Wang, MD. PhD

  Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China

  STUDY DIRECTOR

Central Study Contacts

Jiguang Wang, MD. PhD

CONTACT

+86-2164370045; jiguangw@163.com

Yuanyuan Kang, MD. PhD

CONTACT

+86-2164370045; kangyuanyuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension, Director of the Department of Hypertension

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: December 16, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)