Actively Recruiting
Finerenone for Patients With Primary Aldosteronism (FAIRY)
Led by Qifu Li · Updated on 2024-08-30
306
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
Q
Qifu Li
Lead Sponsor
T
The Affiliated Hospital Of Southwest Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).
CONDITIONS
Official Title
Finerenone for Patients With Primary Aldosteronism (FAIRY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years, male or female
- Confirmed diagnosis of primary aldosteronism with positive screening and at least one confirmatory test
- Not taking any antihypertensive drugs or on a stable regimen limited to alpha-adrenergic receptor blockers and calcium channel blockers for more than four weeks before screening
- Mean seated office systolic blood pressure of 140 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher
- Able and willing to provide informed consent for participation
You will not qualify if you...
- Planned PA subtype classification procedures (e.g., adrenal vein sampling, PET-CT) within 3 months
- Planned surgery within 3 months
- Mean seated office systolic blood pressure 180 mmHg or higher, or diastolic blood pressure 110 mmHg or higher before randomization
- Night shift workers
- Body mass index of 30 kg/m2 or higher at screening
- Uncontrolled diabetes with fasting blood glucose 13.3 mmol/L or higher at screening
- Uncontrolled chronic diseases
- Known secondary hypertension other than subclinical Cushing's syndrome
- Known heart failure (NYHA class III or IV) or liver transaminase levels more than twice the upper limit of normal
- Major cardiac surgery, peripheral arterial bypass surgery, or PCI within 6 months before screening
- Stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening
- Poor compliance preventing full participation
- Hyperkalemia with serum potassium higher than 5.0 mmol/L without potassium supplementation
- History of uncontrolled malignant tumor
- Seated office systolic blood pressure difference of more than 20 mmHg between arms
- Unwilling or unable to stop taking sex hormones, glucocorticoids, NSAIDs, cyclosporine, tacrolimus, or antidepressants
- Pregnant, breastfeeding, or planning pregnancy during the study
- Severe mental illness
- Prior solid organ or cell transplants
- Allergy to finerenone or spironolactone
- Consuming 15 or more alcoholic drinks weekly
- Participation in another investigational drug study within 30 days prior to screening
- Female of childbearing potential refusing to use non-hormonal contraception during the study
- Refusal to stop eating grapefruit or grapefruit juice during finerenone treatment
- Other conditions deemed by the investigator as incompatible with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the first affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
Research Team
S
Shumin Yang
CONTACT
Q
Qifu Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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