Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

September 1, 2018

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
HypertensionObesity
Interventions
DRUG

Eplerenone (-based therapy) arm

At randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM \<130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added \[indapamide (D) 1.25 mg od\]. All groups at both arms will be evaluated at 24 wks by ABPM.

DRUG

Valsartan (-based therapy) arm

At randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM \<130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added \[indapamide (D) 1.25 mg od\]. All groups at both arms will be evaluated at 24 wks by ABPM.

Trial Locations (1)

11527

Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, University of Athens, Athens, Greece, Athens

All Listed Sponsors
lead

Hippocration General Hospital

OTHER

NCT03476616 - Antihypertensive Pharmacological Therapy With Mineralocorticoid Receptor Antagonists in Obese Hypertensive Patients | Biotech Hunter | Biotech Hunter