- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07688928
Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Sharmin Jahan, PhD
- Telefonnummer: +8801731061056
- E-post: sharminendo@bsmmu.edu.bd
Studieorter
-
-
-
Dhaka, Bangladesh, 1000
- Rekrytering
- Endocrine HTN Clinic
-
Kontakt:
- Sharmin Jahan, PhD
- Telefonnummer: +8801731061056
- E-post: sharminendo@bsmmmu.edu.bd
-
Huvudutredare:
- Sharmin Jahan, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Age >18 years.
- History of hypertension (blood pressure >140/90 mm Hg), both newly detected and already established patients.
- 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).
- Serum potassium ≥2.5 mmol/L.
Exclusion Criteria:
- Uncontrolled hypertension (>180/120 mm Hg).
- Lateralized PA patients (aldosterone producing adenoma or unilateral hyperplasia) who want to undergo adrenalectomy or having aldosterone producing carcinoma.
- Participants already with mineralocorticoid receptor antagonist treatment.
- 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.
- Abnormal renal function test: eGFR <60 ml/min-1.73m2.
- Serum potassium level >5 mmol/L.
- Recent cardiovascular events like acute myocardial ischemia, heart failure with hospitalization, stroke or transient ischemic attack ≤3 months before the screening visit.
- Uncontrolled DM (HbA1C >12%)
- Hepatic insufficiency (Child-Pugh C)
- Addison's disease
- 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.
- Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.)
- Known hypersensitivity to the study drugs.
- Patients unwilling to participate in this study
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Finerenone
Tab. Finerenone 10-40mg daily
|
All participants in Finerenone group will get Tab.
Finerenone started at 10mg daily and titrated upto 40mg daily
|
|
Aktiv komparator: Spironolactone
Tab. Spironolactone 25-100mg daily
|
All participants in Finerenone group will get Tab.
Finerenone started at 10mg daily and titrated upto 40mg daily
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dose of Finerenone
Tidsram: 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
|
12 month
|
|
Time required
Tidsram: 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
|
12 month
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Systolic and Diastolic Blood Pressure
Tidsram: 12 month
|
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
Tidsram: 12 month
|
Change in mean systolic and diastolic blood pressure on ambulatory blood pressure monitoring (ABPM).
|
12 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sharmin Jahan, PhD, Professor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PR-1418
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .