nctId: NCT06275763 id: 2020/ABM/01/00037 briefTitle: Optimal Medical Treatment of Difficult-to-treat Hypertension acronym: OPTIMAL-HT overallStatus: RECRUITING date: 2023-10-20 date: 2025-12-01 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: National Institute of Cardiology, Warsaw, Poland class: OTHER briefSummary: 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 conditions: Hypertension studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 2500 type: ESTIMATED name: Phase C: Eplerenone name: Phase C: Spironolactone name: Phase C: Torasemide name: Phase B: Triplixam / Elestar HCT name: Phase A: Confirmation of uncontrolled hypertension measure: Patients with uncontrolled BP on ABPM measure: Patients with controlled BP after 12 weeks on triple SPC measure: Systolic BP reduction on 4th antihypertensive drug measure: Percentage of patients with BP controlled confirmed by HBPM measure: Consistency of the rate of uncontrolled BP measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM measure: Percentage of patients requiring an increase in the dose measure: Consistency of the rate of uncontrolled BP measure: The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks measure: The magnitude of changes in HBPM and ABPM derived indices after 12 weeks measure: Phase C measure: Changes of SBP on ABPM (24h mean) after 12 weeks of treatment measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM measure: Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM measure: Phase C continuation measure: Phase C continuation measure: Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone measure: Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups measure: Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups measure: Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks measure: Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups measure: Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups measure: Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Cardiology status: RECRUITING city: Warsaw state: Mazowieckie zip: 04628 country: Poland name: Agata Skutnik role: CONTACT email: askutnik@ikard.pl lat: 52.22977 lon: 21.01178 hasResults: False