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