Clinical trial
A Double-blind, Randomized Controlled Study of Finerenone vs. Spironolactone in Hypertensive Patients With Primary Aldosteronism
Name
FAVOR
Description
To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism
Trial arms
Trial start
2023-12-16
Estimated PCD
2024-12-16
Trial end
2024-12-16
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Finerenone group
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.
Arms:
Spironolactone group
Size
150
Primary endpoint
The change of 24-hour ambulatory systolic blood pressure from the baseline level.
8 weeks
The proportion of patients with normal serum potassium level.
8 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-12-11
1 organization
2 products
1 indication
Organization
Shanghai Jiao Tong University School of MedicineProduct
FinerenoneIndication
Primary AldosteronismProduct
Spironolactone