NCT04331691

Comparison of Spironolactone and Amiloride on Home Blood Pressure in Resistant Hypertension

SPironolactone Versus Amiloride for Treatment of REsistant Hypertension (SPARE Trial): A Comparison of Home Blood Pressure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The subjects with office SBP of 130-180 mmHg with 3 antihypertensive medications of different classes including thiazide or thiazide-like diuretics and daytime average daytime SBP of ≥ 130 mmHg are enrolled in the 4-week run-in period. During run-in period, subjects will receive sevikar HCT (5/20/12.5 mg, 5/40/12.5 mg or 10/40/12.5 mg). After a 4-week run-in period, subjects who have uncontrolled average home SBP, defined as average SBP of ≥ 130 mmHg, will be randomized to either spironolactone or amiloride. 118 subjects will be randomly assigned to one of the two treatment groups. Subjects randomly assigned to one of the two treatment groups will receive 12.5 mg of spironolactone and the other group will receive 5 mg of amiloride. Subjects who did not reach the target blood pressure after 4 weeks of treatment should be increased to 25 mg of spironolactone or 10 mg of amiloride. After 12 weeks of treatment, study will be end.

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
DRUG	Spironolactone	After randomization, this group will receive 12.5 mg of spironolactone daily. Subjects who did not reach the target blood pressure after 4 weeks of treatment should be increased to 25 mg of spironolactone. After 12 weeks of treatment, study will be end.
DRUG	Amiloride	After randomization, this group will receive 5 mg of amiloride daily. Subjects who did not reach the target blood pressure after 4 weeks of treatment should be increased to 10 mg of amiloride. After 12 weeks of treatment, study will be end.

Timeline

• Start date: 2020-11-16
• Primary completion: 2024-05-23
• Completion: 2024-05-23
• First posted: 2020-04-02
• Last updated: 2024-09-24

Locations

1 site across 1 country: South Korea