Comparison of Spironolactone and Amiloride on Home Blood Pressure in Resistant Hypertension
Status:
Not yet recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Resistant hypertension is defined as blood pressure that remains above goal despite
concurrent use of three antihypertensive agents of different classes including diuretics.
Patients with resistant hypertension has at least 1.5-fold higher cardiovascular risk than
those with non-resistant hypertension. Therefore, controlling blood pressure is crucial in
patients with resistant hypertension.
It has been unclear which antihypertensive agent should be added in patients who cannot reach
target blood pressure despite use of three antihypertensive agents. There have been three
randomized clinical trials that proved the efficacy of spironolactone in resistant
hypertension, but they were small sized, comparison study to placebo. Recently published
PATHWAY-2 study which compared the efficacy of spironolactone with placebo, doxazosin, and
bisoprolol showed superiority of spironolactone in blood pressure lowering in patients with
resistant hypertension. Thus, revised ACC/AHA and ESC/ESH guideline for arterial hypertension
recommended spironolactone as the fourth agent for resistant hypertension. However, in real
world, adherence to spironolactone may not be adequate because of adverse effect such as
gynecomastia, hyperkalemia, and so on.
Recently, sub-study of PATHWAY-2 revealed that amiloride changes systolic blood pressure by
-22.2 mmHg (95% CI, -24.7 to -19.7) which is comparable with the effect of spironolactone
(-21.8 mmHg; 95% CI, -24.2 to -19.3). However, it was not randomized clinical trial to
compare the effect between spironolactone and amiloride in patients with resistant
hypertension.
This study aims to compare the effect of spironolactone and amiloride on home blood pressure
in resistant hypertensive patients and to compare the rate of target blood pressure
achievement between spironolactone and amiloride in resistant hypertensive patients.