NCT06275763

Optimal Medical Treatment of Difficult-to-treat Hypertension

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: National Institute of Cardiology, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate best medical management to achieve the BP goals of ESC/ESH (120-129 / 70-79 mmHg) in HT patients who are \<65 years old and ineffectively treated (BP ≥ 130/80 mg) with 3 or more antihypertensive drugs

Detailed description

Purpose: To evaluate best medical management to achieve the ESC/ESH 2018 BP goals of 120-129 / 70-79 mmHg in HT patients aged \< 65 y not controlled on 3 or more antihypertensive drugs. Study design: Phase A (Active screening) (n = 2500) 7 days Confirmation of the true ineffectiveness of antihypertensive therapy based on 3 or more antihypertensive drugs (single or dual drug preparations) using ABPM and home BP measurements. Phase B (Open-label, non-randomized) (n = 1250) 12 weeks Replacement of ineffective antihypertensive treatment based on 3 or more antihypertensive drugs (single or dual drug preparations) with a triple single pill combination (SPC) based on optimally combined antihypertensive drugs: perindopril + indapamide + amlodipine (P+I+A) or olmesartan + hydrocholothiazide + amlodipine (O+H+A). Phase C (Double blind, randomized, parallel-group) (n = 480) 24 weeks Comparison of antihypertensive efficacy and tolerability profile: * spironolactone * eplerenone * torasemide attached as an antihypertensive drug of 4th choice.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Phase C: Eplerenone	Participants randomly assigned to this arm take Eplerenone and placebos of Spironolactone and Torasemide
DRUG	Phase C: Spironolactone	Participants randomly assigned to this arm take Spironolactone and placebos of Eplerenone and Torasemide
DRUG	Phase C: Torasemide	Participants randomly assigned to this arm take Torasemide and placebos of Eplerenone and Spironolactone
DRUG	Phase B: Triplixam / Elestar HCT	Replacement of ineffective antihypertensive treatment based on 3 or more antihypertensive drugs (single or dual drug preparations) with a triple single pill combination (SPC) based on optimally combined antihypertensive drugs: perindopril + indapamide + amlodipine (P+I+A) or olmesartan + hydrocholothiazide + amlodipine (O+H+A).
DIAGNOSTIC_TEST	Phase A: Confirmation of uncontrolled hypertension	Confirmation of the true ineffectiveness of antihypertensive therapy based on 3 or more antihypertensive drugs (single or dual drug preparations) using ABPM and home BP measurements.

Timeline

• Start date: 2023-10-20
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2024-02-23
• Last updated: 2024-02-23

Locations

1 site across 1 country: Poland