Endocrine Hypertension, Primary Aldosteronism
Conditions
Keywords
Primary Aldosteronism, Finerenone, Spironolactone
Brief summary
The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism. It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of Endocrinology, BSMMU. A total of 104 adult patients with confirmed primary aldosteronism will be enrolled and randomized equally to receive either finerenone (10-40 mg/day) or spironolactone (25-100mg/day) for 48 weeks. Study drugs will be titrated to achieve target blood pressure (\<140/90mmHg) and unsuppressed plasma renin concentration (\>15 mU/L). The primary efficacy outcome will be the time and daily dose required to attain this composite endpoint. Secondary outcomes include changes in clinic and ambulatory blood pressure, plasma aldosterone and renin levels, renal function (eGFR), urinary albumin excretion, left ventricular mass index, and quality of life. Safety outcomes will include adverse events, particularly hyperkalaemia and deterioration of renal function.
Interventions
DRUGFinerenone
All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily
Sponsors
Bangladesh Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years. 2. History of hypertension (blood pressure \>140/90 mm Hg), both newly detected and already established patients. 3. Diagnosed case of primary aldosteronism (PA) based on a screening test (increased aldosterone renin ration (ARR) \>70pmol/L) and confirmed by saline suppression test (post-saline PAC \>170pmol/L, where PAC measured by immunoassay). 4. Serum potassium ≥2.5 mmol/L.
Exclusion criteria
1. Uncontrolled hypertension (\>180/120 mm Hg). 2. Lateralized PA patients (aldosterone producing adenoma or unilateral hyperplasia) who want to undergo adrenalectomy or having aldosterone producing carcinoma. 3. Participants already with mineralocorticoid receptor antagonist treatment. 4. Patients receiving medications confounding PAC or PRC (glucocorticoids, sodium glucose co-transporter 2 inhibitors (SGLT-2i) or systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, clarithromycin, rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz) that cannot be discontinued 14 days prior to randomization or for the duration of treatment period. 5. Abnormal renal function test: eGFR \<60 ml/min-1.73m2. 6. Serum potassium level \>5 mmol/L. 7. Recent cardiovascular events like acute myocardial ischemia, heart failure with hospitalization, stroke or transient ischemic attack ≤3 months before the screening visit. 8. Uncontrolled DM (HbA1C \>12%) 9. Hepatic insufficiency (Child-Pugh C) 10. Addison's disease 11. Pregnant and lactating women. Women with child bearing potential must agree to use adequate contraception during and until 2 month of the end of study period. 12. Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.) 13. Known hypersensitivity to the study drugs. 14. Patients unwilling to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Finerenone | 12 month | daily dose of finerenone required for attainment of composite endpoints of target blood pressure (\<140/90 mmHg) and unsuppressed plasma renin concentration (\>15 mU/L) from baseline in participants with PA |
| Time required | 12 month | Time required for attainment of composite endpoints of target blood pressure (\<140/90mmHg) and unsuppressed plasma renin concentration (\>15 mU/L) from baseline in participants with PA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure | 12 month | Change in mean clinic systolic and diastolic blood pressure from baseline to the end of 48 weeks treatment period. |
| Change in Blood pressure in ABPM | 12 month | Change in mean systolic and diastolic blood pressure on ambulatory blood pressure monitoring (ABPM). |
Countries
Bangladesh
Contacts
CONTACTSharmin Jahan, PhD
PRINCIPAL_INVESTIGATORSharmin Jahan, PhD
Professor
Outcome results
None listed