Spironolactone Versus Amiloride as an Add on Agent in Resistant Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/5/2014 |
| Start Date: | October 2008 |
| End Date: | November 2010 |
| Contact: | Richard S Rose, MD |
| Email: | richard.rose@hsc.utah.edu |
| Phone: | 801-953-3004 |
Randomized Trial of Spironolactone Versus Amiloride as an Add on Agent in Resistant Hypertension
Joint National Committee 7 (JNC-7) defines resistant hypertension as a persistent elevation
of blood pressure (BP) above goal - ≥ 140/90 mm Hg for the general hypertensive population
or ≥ 130/80 mm Hg for persons with diabetes mellitus or chronic kidney disease - for at
least three months despite treatment with three or more optimally dosed antihypertensive
agents, including a diuretic. The exact prevalence of resistant hypertension is uncertain
but may include 5-20% of hypertensive persons in primary care settings and 15-35% of the
older, higher cardiovascular risk hypertensive patients incorporated into recent clinical
trials of antihypertensive therapy. Observational studies demonstrate that patients with
resistant hypertension experience a higher rate of cardiovascular and renal target organ
damage such as left ventricular hypertrophy, microalbuminuria, and renal insufficiency and
more cardiovascular disease (CVD) events than patients whose hypertension is
well-controlled. Additionally, resistant hypertension patients may be subjected to the
considerable expense of multiple office visits, diagnostic testing for secondary causes of
hypertension, and referral to hypertension specialists. Because multiple factors can
contribute to resistant hypertension, an explicit, sequential approach to evaluation and
management is essential to optimize blood pressure, reduce cardiorenal morbidity and
mortality, and avoid unnecessary expense. A number of observational studies have suggested
the potential efficacy of both spironolactone and amiloride when added to a 3 drug
antihypertensive regimen, but to date no randomized study has directly compared the two
agents. The goal of this study is to determine whether spironolactone or amiloride is the
more effective fourth agent to add to a three drug regimen in patients with resistant
hypertension.
of blood pressure (BP) above goal - ≥ 140/90 mm Hg for the general hypertensive population
or ≥ 130/80 mm Hg for persons with diabetes mellitus or chronic kidney disease - for at
least three months despite treatment with three or more optimally dosed antihypertensive
agents, including a diuretic. The exact prevalence of resistant hypertension is uncertain
but may include 5-20% of hypertensive persons in primary care settings and 15-35% of the
older, higher cardiovascular risk hypertensive patients incorporated into recent clinical
trials of antihypertensive therapy. Observational studies demonstrate that patients with
resistant hypertension experience a higher rate of cardiovascular and renal target organ
damage such as left ventricular hypertrophy, microalbuminuria, and renal insufficiency and
more cardiovascular disease (CVD) events than patients whose hypertension is
well-controlled. Additionally, resistant hypertension patients may be subjected to the
considerable expense of multiple office visits, diagnostic testing for secondary causes of
hypertension, and referral to hypertension specialists. Because multiple factors can
contribute to resistant hypertension, an explicit, sequential approach to evaluation and
management is essential to optimize blood pressure, reduce cardiorenal morbidity and
mortality, and avoid unnecessary expense. A number of observational studies have suggested
the potential efficacy of both spironolactone and amiloride when added to a 3 drug
antihypertensive regimen, but to date no randomized study has directly compared the two
agents. The goal of this study is to determine whether spironolactone or amiloride is the
more effective fourth agent to add to a three drug regimen in patients with resistant
hypertension.
Inclusion Criteria:
- Participants will be selected from a broad range of medical clinics at the Salt Lake
City VA Medical Center and surrounding community based outpatient clinics (CBOCs).
- The participants will be referred to a resistant hypertension clinic by either their
primary care provider or by a subspecialist. The referrals are made via a
computerized system that is used in the Veterans Affairs Medical Center (VA) called
Computerized Patient Record System (CPRS).
- Patients are referred if their blood pressure is above goal as defined by JNC 7 and
they are on 3 antihypertensive medications with one of the agents being a diuretic.
- All patients age 18 -80 years old.
Exclusion Criteria:
- Patients that will be excluded from the study if they have had a documented adverse
reaction to either spironolactone or amiloride.
- diagnosis of primary hyperaldosteronism
- inability to adhere to frequent laboratory monitoring
- estimated glomerular filtration rate (GFR) < 45 ml/min/1.73m2
- baseline serum potassium above 5.0 mEq/L
- type 4 renal tubular acidosis
- pregnancy
- heart failure that meets criteria for using either eplerenone or spironolactone
- current unstable renal function
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