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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finerenone | Experimental | Tab. Finerenone 10-40mg daily |
|
| Spironolactone | Active Comparator | Tab. Spironolactone 25-100mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone | Drug | All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose of Finerenone | 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 | 12 month |
| Time required | 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 | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure | Change in mean clinic systolic and diastolic blood pressure from baseline to the end of 48 weeks treatment period. | 12 month |
| Change in Blood pressure in ABPM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharmin Jahan, PhD | Contact | +8801731061056 | sharminendo@bsmmu.edu.bd |
| Name | Affiliation | Role |
|---|---|---|
| Sharmin Jahan, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrine HTN Clinic | Recruiting | Dhaka | 1000 | Bangladesh |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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Change in mean systolic and diastolic blood pressure on ambulatory blood pressure monitoring (ABPM).
| 12 month |