BridgeMD
Optimal medical treatment of difficult-to-treat hypertension.
EU CTIS ID: 2024-517628-20-00
What this study is testing
Phase A: - Percentage of patients with uncontrolled BP confirmed on ABPM (24h mean, SBP ≥125 mm Hg or DBP ≥80 mm Hg) Phase B: - 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. Phase C: - Magnitude of reduction of SBP on ABPM (24h mean) after 12 weeks of treatment – comparison of eplerenone vs spironolactone and torasemide vs spironolactone.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women and men
- Age: ≥18 years old, less than 75 years old
- 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 angiotensin converting enzyme inhibitor / angiotensin II receptor blocker (ACEi/ARB) and a thiazide/thiazide-like diuretic (TD/TLD) or loop diuretic (single drugs or double SPCs) (any association) or a threecomponent SPC based on drugs other than those used in the study)
You likely can't join if
- Inability to give informed consent
- Heart failure with an ejection fraction ≤50%
- Cardiomyopathy
- Severe valvular disease
- Aortic aneurysm
- Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. chronic coronary syndromes) such that discontinuation might pose serious risk to health
See the full eligibility criteria
- Women and men
- Age: ≥18 years old, less than 75 years old
- 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 angiotensin converting enzyme inhibitor / angiotensin II receptor blocker (ACEi/ARB) and a thiazide/thiazide-like diuretic (TD/TLD) or loop diuretic (single drugs or double SPCs) (any association) or a threecomponent SPC based on drugs other than those used in the study)
- 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
- Inability to give informed consent
- Heart failure with an ejection fraction ≤50%
- Cardiomyopathy
- Severe valvular disease
- Aortic aneurysm
- Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. chronic coronary syndromes) such that discontinuation might pose serious risk to health
- Documented history of persistent or permanent atrial tachyarrhythmia requiring beta-blocker treatment
- 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
- Office SBP ≥180 mm Hg and/or DBP ≥110 mm Hg and/or DBP <60 mm Hg
- 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, hormone therapy);
- 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
- BMI ≥45 kg/m2
- eGFR of <45 mL/min/1.73 m2
- Potassium serum concentration > 5 mmol/L or < 3.5 mmol/L within the year prior to the screening visit
- Persistent hyponatremia or history of hyponatremia related to TD/TLD treatment (sodium concentration <135 mmol/L)
- Secondary or accelerated hypertension (not including sleep apnea)
- Chronic glucocorticoid therapy
- Myocardial infarction or cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) in the year prior to study inclusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.