HypertensionPhase 4OPTIMAL-HTNCT06275763
Optimal Medical Treatment of Difficult-to-treat Hypertension
A Phase 4 study testing Phase C: Eplerenone, Phase C: Spironolactone and Phase C: Torasemide in people with Hypertension, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Phase C: Eplerenone, Phase C: Spironolactone and Phase C: Torasemide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 sitePoland
- Study dates
- 20 Oct 2023to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented history of HT
- HT treated for at least six months,
- office BP ≥ 130 and / or ≥80 mm Hg (average seated BP at Visit 1)
- use of 3 or more antihypertensive drugs, including an ACEi/ARB and a thiazide/thiazide-like diuretic or loop diuretic (single drugs or double SPCs)
- stable antihypertensive treatment regimen - no changes in antihypertensive treatment strategy at least for 4 weeks
- able and willing to comply with all study procedures and able to attend one of the study centers
Who cannot join
- inability to give informed consent
- SBP ≥180 mm Hg and/or DBP ≥110 mm Hg and/or DBP <60 mm Hg
- BMI ≥40 kg/m2
- eGFR of <45 mL/min/1.73 m2
- potassium serum concentration > 4.8 mmol/L or < 3.5 mmol/L
- persistent hyponatremia or history of hyponatremia related to TD/TLD treatment (sodium concentration <135 mmol/L)
Show all 24Show fewer
- secondary hypertension (not including sleep apnea)
- chronic oral glucocorticoid therapy
- myocardial infarction or cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) in the year prior to study inclusion
- heart failure requiring treatment with diuretic or aldosterone antagonists
- cardiomyopathy exluding LVH related to HT
- severe valvular disease
- ascending aortic aneurysm ≥5 cm
- prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. chronic coronary syndromes, arytmia) such that discontinuation might pose serious risk to health
- primary pulmonary hypertension
- decompensated hyperthyroidism or hypothyroidism
- severe liver dysfunction (alanine aminotransferase and/or asparagine aminotransferase activity ≥3 times the upper limit of normal value),
- documented contraindication or allergy to studied drugs
- limited life expectancy of < 1 year at the discretion of the Investigator
- any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements
- all women of child bearing potential; women of child bearing potential can be included in the study ONLY after providing documentation of effective contraception (intrauterine device);
- concurrent enrollment in any other investigational drug or device trial
- anticipated change of medical status during the trial (e.g., surgical intervention requiring >2 weeks convalescence)
- current therapy for cancer
Trial locations and contacts
1 site in 1 country.
Aleksander Prejbisz, Professor contact
Poland1 site, 1 recruiting
- Recruiting
National Institute of Cardiology
Warsaw, Masovian Voivodeship, 04628
Agata Skutnik, askutnik@ikard.pl
About this study
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
Read the 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
- Being tested
- Phase C: Eplerenone, Phase C: Spironolactone, Phase C: Torasemide, Phase B: Triplixam / Elestar HCT, Phase A: Confirmation of uncontrolled hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase C: EplerenoneDrug
Also called Eplerenone
Participants randomly assigned to this arm take Eplerenone and placebos of Spironolactone and Torasemide
Phase C: SpironolactoneDrug
Also called Spironolactone
Participants randomly assigned to this arm take Spironolactone and placebos of Eplerenone and Torasemide
Phase C: TorasemideDrug
Also called Torasemide
Participants randomly assigned to this arm take Torasemide and placebos of Eplerenone and Spironolactone
Phase B: Triplixam / Elestar HCTDrug
Also called Triple Single Pill Combination: 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).
Phase A: Confirmation of uncontrolled hypertensionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone (+placebo of Spironolactone and placebo of Torasemide) | Experimental | Phase C. Participants randomly assigned to this arm take Eplerenone and placebos of Spironolactone and Torasemide Receives: Drug: Phase C: Eplerenone; Drug: Phase B: Triplixam / Elestar HCT |
| Spironolactone (+placebo of Eplerenone and placebo of Torasemide) | Experimental | Phase C. Participants randomly assigned to this arm take Spironolactone and placebos of Eplerenone and Torasemide Receives: Drug: Phase C: Spironolactone; Drug: Phase B: Triplixam / Elestar HCT |
| Torasemide (+placebo of Eplerenone and placebo of Spironolactone ) | Experimental | Phase C. Participants randomly assigned to this arm take Torasemide and placebos of Eplerenone and Spironolactone Receives: Drug: Phase C: Torasemide; Drug: Phase B: Triplixam / Elestar HCT |
| Open-label | Active comparator | Phase B 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). Receives: Drug: Phase B: Triplixam / Elestar HCT |
| Screening | Other | Phase A. 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. Receives: Diagnostic Test: Phase A: Confirmation of uncontrolled hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with uncontrolled BP on ABPM
Percentage of patients with uncontrolled BP confirmed on ABPM (24h mean, SBP ≥125 mm Hg or DBP ≥80 mm Hg)
Measured: First week of the patients' participation in the study
Patients with controlled BP after 12 weeks on triple SPC
Percentage of patients with controlled BP after 12 weeks of treatment with triple SPC, confirmed on ABPM (24h mean, SBP <125 mm Hg and DBP <80 mm Hg) - as the efficacy of the treatment strategy (switching ineffective treatment to triple SPC) - the whole group and P+I+A and E+H+A groups separetly.
Measured: Next 12 weeks of the patients' participation in the study
Systolic BP reduction on 4th antihypertensive drug
Magnitude of reduction of SBP on ABPM (24h mean) after 12 weeks of treatment - comparison of eplerenone vs spironolactone and torasemide vs spironolactone.
Measured: Last 24 weeks of the patients' participation in the study
Secondary outcomes (26)
Percentage of patients with BP controlled confirmed by HBPM
Percentage of patients with BP controlled confirmed by HBPM (mean over the period of 6 days, SBP ≥130 mm Hg or DBP ≥80 mm Hg)
Measured: First week of the patients' participation in the study
Consistency of the rate of uncontrolled BP
Consistency of the rate of uncontrolled BP between ABPM and HBPM
Measured: First week of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM (SBP <130 mm Hg and DBP <80 mm Hg).
Measured: Next 12 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM (mean over 6 days, SBP <130 mm Hg and DBP <80 mm Hg).
Measured: Next 12 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM in daytime (SBP <135 mm Hg and DBP <85 mm Hg) and nighttime (SBP <120 mm Hg and DBP <70 mm Hg) reading.
Measured: Next 12 weeks of the patients' participation in the study
Percentage of patients requiring an increase in the dose
Percentage of patients requiring an increase in the dose of drugs used in the whole group and in the patients treated with P+I+A and O+H+A separately.
Measured: Next 12 weeks of the patients' participation in the study
Consistency of the rate of uncontrolled BP
Consistency of the rate of uncontrolled BP between ABPM, HBPM and OBPM.
Measured: Next 12 weeks of the patients' participation in the study
The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks
The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks of treatment in the whole group and in the patients treated with P+I+A and O+H+A separately.
Measured: Next 12 weeks of the patients' participation in the study
The magnitude of changes in HBPM and ABPM derived indices after 12 weeks
The magnitude of changes in HBPM and ABPM derived indices after 12 weeks of treatment in the whole group and in the patients treated with P+I+A and O+H+A separately.
Measured: Next 12 weeks of the patients' participation in the study
Phase C
- Changes of SBP on ABPM (24h mean) after 12 weeks of treatment in patients receiving spironolactone, eplerenone or torasemide as compared against baseline.
- Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM (SBP <130 mm Hg and DBP <80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group.
- Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM (mean over 6 days, SBP <130 mm Hg and DBP <80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group.
- Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM, in 24h mean (SBP <125 mm Hg and DBP <80 mm Hg), daytime (SBP <135 mm Hg and DBP <85 mm Hg) and nighttime (SBP <120 mm Hg and DBP <70 mm Hg) readings - comparison of eplerenone / torasemide groups against the spironolactone group.
Measured: Last 24 weeks of the patients' participation in the study
Changes of SBP on ABPM (24h mean) after 12 weeks of treatment
Changes of SBP on ABPM (24h mean) after 12 weeks of treatment in patients receiving spironolactone, eplerenone or torasemide as compared against baseline.
Measured: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM (SBP <130 mm Hg and DBP <80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group.
Measured: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM (mean over 6 days, SBP <130 mm Hg and DBP <80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group.
Measured: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM, in 24h mean (SBP <125 mm Hg and DBP <80 mm Hg), daytime (SBP <135 mm Hg and DBP <85 mm Hg) and nighttime (SBP <120 mm Hg and DBP <70 mm Hg) readings - comparison of eplerenone / torasemide groups against the spironolactone group.
Measured: Last 24 weeks of the patients' participation in the study
Phase C continuation
Consistency of the rate of controlled BP between ABPM, HBPM and OBPM (after 12 weeks of treatment).
Measured: Last 24 weeks of the patients' participation in the study
Phase C continuation
Changes in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks of treatment - comparison of eplerenone / torasemide groups against the spironolactone group and comparison of each of the studied drug groups against baseline.
Measured: Last 24 weeks of the patients' participation in the study
Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups
Changes in HBPM and ABPM derived indices after 12 weeks of treatment - comparison of eplerenone / torasemide groups against the spironolactone group and comparison of each of the studied drug groups against baseline
Measured: Last 24 weeks of the patients' participation in the study
Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone
Changes of SBP on ABPM (24h mean) after 24 weeks of treatment in patients receiving eplerenone or torasemide as compared against spironolactone.
Measured: Last 24 weeks of the patients' participation in the study
Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline
Changes of SBP on ABPM (24h mean) after 24 weeks of treatment in patients receiving spironolactone, eplerenone or torasemide as compared against baseline.
Measured: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM (SBP <130 mm Hg and DBP <80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group.
Measured: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM (mean over 6 days, SBP <130 mm Hg and DBP <80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group.
Measured: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM, in 24h mean (SBP <125 mm Hg and DBP <80 mm Hg), daytime (SBP <135 mm Hg and DBP <85 mm Hg) and nighttime (SBP <120 mm Hg and DBP <70 mm Hg) readings - comparison of eplerenone / torasemide groups against the spironolactone group.
Measured: Last 24 weeks of the patients' participation in the study
Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks
Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks of treatment
Measured: Last 24 weeks of the patients' participation in the study
Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups
Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison of eplerenone / torasemide groups against the spironolactone group and comparison of each of the studied drug groups against baseline.
Measured: Last 24 weeks of the patients' participation in the study
Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups
Changes in HBPM and ABPM derived indices after 24 weeks of treatment - comparison of eplerenone / torasemide groups against the spironolactone group and comparison of each of the studied drug groups against baseline
Measured: Last 24 weeks of the patients' participation in the study
Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups
Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison of eplerenone / torasemide groups against the spironolactone.
Measured: Last 24 weeks of the patients' participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start20 Oct 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Dobrowolski, Professor, Principal investigator, National Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275763
- Sponsor's protocol ID
- 2020/ABM/01/00037
- Acronym
- OPTIMAL-HT
- Status last verified
- May 2023
- First submitted
- 4 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Medical Treatment of Difficult-to-treat Hypertension
- ClinicalTrials.gov ID
- NCT06275763
- Acronym / sponsor ID
- OPTIMAL-HT / 2020/ABM/01/00037
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Eplerenone (+placebo of Spironolactone and placebo of Torasemide) | Experimental | Drug: Phase C: Eplerenone, Drug: Phase B: Triplixam / Elestar HCTPhase C. Participants randomly assigned to this arm take Eplerenone and placebos of Spironolactone and Torasemide |
| Spironolactone (+placebo of Eplerenone and placebo of Torasemide) | Experimental | Drug: Phase C: Spironolactone, Drug: Phase B: Triplixam / Elestar HCTPhase C. Participants randomly assigned to this arm take Spironolactone and placebos of Eplerenone and Torasemide |
| Torasemide (+placebo of Eplerenone and placebo of Spironolactone ) | Experimental | Drug: Phase C: Torasemide, Drug: Phase B: Triplixam / Elestar HCTPhase C. Participants randomly assigned to this arm take Torasemide and placebos of Eplerenone and Spironolactone |
| Open-label | Active comparator | Drug: Phase B: Triplixam / Elestar HCTPhase B 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). |
| Screening | Other | Diagnostic Test: Phase A: Confirmation of uncontrolled hypertensionPhase A. 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- documented history of HT
- HT treated for at least six months,
- office BP ≥ 130 and / or ≥80 mm Hg (average seated BP at Visit 1)
- use of 3 or more antihypertensive drugs, including an ACEi/ARB and a thiazide/thiazide-like diuretic or loop diuretic (single drugs or double SPCs)
- stable antihypertensive treatment regimen - no changes in antihypertensive treatment strategy at least for 4 weeks
Key exclusion criteria (24 listed)
- inability to give informed consent
- SBP ≥180 mm Hg and/or DBP ≥110 mm Hg and/or DBP <60 mm Hg
- BMI ≥40 kg/m2
- eGFR of <45 mL/min/1.73 m2
- potassium serum concentration > 4.8 mmol/L or < 3.5 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase C: EplerenoneAlso: EplerenoneParticipants randomly assigned to this arm take Eplerenone and placebos of Spironolactone and Torasemide | Drug | Eplerenone (+placebo of Spironolactone and placebo of Torasemide) |
| Phase C: SpironolactoneAlso: SpironolactoneParticipants randomly assigned to this arm take Spironolactone and placebos of Eplerenone and Torasemide | Drug | Spironolactone (+placebo of Eplerenone and placebo of Torasemide) |
| Phase C: TorasemideAlso: TorasemideParticipants randomly assigned to this arm take Torasemide and placebos of Eplerenone and Spironolactone | Drug | Torasemide (+placebo of Eplerenone and placebo of Spironolactone ) |
| Phase B: Triplixam / Elestar HCTAlso: Triple Single Pill Combination: Triplixam / Elestar HCTReplacement 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). | Drug | Eplerenone (+placebo of Spironolactone and placebo of Torasemide), Open-label, Spironolactone (+placebo of Eplerenone and placebo of Torasemide), Torasemide (+placebo of Eplerenone and placebo of Spironolactone ) |
| Phase A: Confirmation of uncontrolled hypertensionConfirmation 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. | Diagnostic test | Screening |
Primary outcome
Patients with uncontrolled BP on ABPM
Time frame: First week of the patients' participation in the study
Percentage of patients with uncontrolled BP confirmed on ABPM (24h mean, SBP ≥125 mm Hg or DBP ≥80 mm Hg)
Patients with controlled BP after 12 weeks on triple SPC
Time frame: Next 12 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment with triple SPC, confirmed on ABPM (24h mean, SBP <125 mm Hg and DBP <80 mm Hg) - as the efficacy of the treatment strategy (switching ineffective treatment to triple SPC) - the whole group and P+I+A and E+H+A groups separetly.
Systolic BP reduction on 4th antihypertensive drug
Time frame: Last 24 weeks of the patients' participation in the study
Magnitude of reduction of SBP on ABPM (24h mean) after 12 weeks of treatment - comparison of eplerenone vs spironolactone and torasemide vs spironolactone.
26 secondary outcomes
Percentage of patients with BP controlled confirmed by HBPM
Time frame: First week of the patients' participation in the study
Consistency of the rate of uncontrolled BP
Time frame: First week of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM
Time frame: Next 12 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM
Time frame: Next 12 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM
Time frame: Next 12 weeks of the patients' participation in the study
Percentage of patients requiring an increase in the dose
Time frame: Next 12 weeks of the patients' participation in the study
Consistency of the rate of uncontrolled BP
Time frame: Next 12 weeks of the patients' participation in the study
The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks
Time frame: Next 12 weeks of the patients' participation in the study
The magnitude of changes in HBPM and ABPM derived indices after 12 weeks
Time frame: Next 12 weeks of the patients' participation in the study
Phase C
Time frame: Last 24 weeks of the patients' participation in the study
Changes of SBP on ABPM (24h mean) after 12 weeks of treatment
Time frame: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM
Time frame: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM
Time frame: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM
Time frame: Last 24 weeks of the patients' participation in the study
Phase C continuation
Time frame: Last 24 weeks of the patients' participation in the study
Phase C continuation
Time frame: Last 24 weeks of the patients' participation in the study
Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups
Time frame: Last 24 weeks of the patients' participation in the study
Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against spironolactone
Time frame: Last 24 weeks of the patients' participation in the study
Changes of SBP on ABPM (24h mean) after 24 weeks of treatment compared against baseline
Time frame: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by OBPM - comparison between groups
Time frame: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by HBPM - comparison between groups
Time frame: Last 24 weeks of the patients' participation in the study
Percentage of patients with controlled BP after 24 weeks of treatment, confirmed by ABPM - comparison between groups
Time frame: Last 24 weeks of the patients' participation in the study
Consistency of the rate of controlled BP between ABPM, HBPM and OBPM after 24 weeks
Time frame: Last 24 weeks of the patients' participation in the study
Changes in SBP and DBP on OBPM, ABPM and HBPM after 24 weeks of treatment - comparison between groups
Time frame: Last 24 weeks of the patients' participation in the study
Changes in HBPM and ABPM derived indices after 24 weeks of treatment - - comparison between groups
Time frame: Last 24 weeks of the patients' participation in the study
Percentage of patients requiring an increase in the dose of drugs used after 6 and 12 weeks - comparison between groups
Time frame: Last 24 weeks of the patients' participation in the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksander Prejbisz, Professor contact
Piotr Dobrowolski, Professor principal investigator
National Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phase C: Eplerenone, Phase C: Spironolactone and Phase C: Torasemide in people with Hypertension, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Dobrowolski, Professor ((+48) 228156556 ext. 4850, pdobrowolski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with uncontrolled BP on ABPM (time frame: First week of the patients' participation in the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.