Optimal treatment for difficult-to-treat hypertension

Optimal Medical Treatment of Difficult-to-treat Hypertension

This study is testing the best ways to manage high blood pressure in people under 65 who still struggle to control it despite taking three or more medications.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: National Institute of Cardiology, Warsaw, Poland (Academic / other)
• Locations: 1 site (Warsaw, Mazowieckie)
• Trial ID: NCT06275763 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the best medical management strategies to achieve blood pressure goals in patients under 65 years old who have hypertension that is not adequately controlled with three or more antihypertensive medications. The study is divided into three phases: an active screening phase to confirm treatment ineffectiveness, an open-label phase where ineffective treatments are replaced with a triple combination pill, and a double-blind phase comparing the efficacy and tolerability of additional antihypertensive medications. The goal is to find the most effective treatment regimen for these patients.

Who should consider this trial

Good fit: Ideal candidates are patients under 65 years old with hypertension that remains uncontrolled despite being treated with three or more antihypertensive drugs.

Not a fit: Patients with secondary hypertension or those with severe hypertension (SBP ≥180 mm Hg) may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved blood pressure control in patients with difficult-to-treat hypertension.

How similar studies have performed: Other studies have shown promise in optimizing treatment for hypertension, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Where this trial is running

Warsaw, Mazowieckie

• National Institute of Cardiology — Warsaw, Mazowieckie, Poland (Recruiting)

Study contacts

• Principal investigator: Piotr Dobrowolski, Professor — National Institute of Cardiology
• Study coordinator: Piotr Dobrowolski, Professor

Conditions Hypertension