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Sponsored by: |
VA Salt Lake City Health Care System |
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Information provided by: | VA Salt Lake City Health Care System |
ClinicalTrials.gov Identifier: | NCT00709137 |
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.
Condition | Intervention |
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Resistant Hypertension |
Drug: spironolactone Drug: amiloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of Spironolactone Versus Amiloride as an Add on Agent in Resistant Hypertension |
Estimated Enrollment: | 80 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
this arm will include patients with resistant hypertension who are on 3 reasonably dosed agents (one being an appropriately dosed diuretic) and spironolactone will be added (dose range 12.5mg-50mg)
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Drug: spironolactone
tablet form. doses used range from 12.5-50mg po QDAY. Total duration would be until completion or study or medication intolerance.
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2: Active Comparator
this arm will include patients with resistant hypertension who are on 3 reasonably dosed agents (one being an appropriately dosed diuretic) and amiloride will be added (dose range 2.5-10mg)
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Drug: amiloride
amiloride 2.5-10 mg po QDAY. Duration until completion of study or until tolerance
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard S Rose, MD | 801-953-3004 | richard.rose@hsc.utah.edu |
Contact: Amelia Underwood, MD | amelia.underwood@va.gov |
United States, Utah | |
VAMC SLC - George Wahlen VA | |
SLC, Utah, United States, 84148 |
Principal Investigator: | Richard S Rose, MD | Univ of Utah Division of General Internal Medicine; VAMC SLC Internal Medicine |
Responsible Party: | VAMC SLC; University of Utah Division of General Internal Medicine ( Richard Rose, MD ) |
Study ID Numbers: | IRB_00027466 |
Study First Received: | July 1, 2008 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00709137 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
resistant hypertensions spironolactone amiloride ambulatory blood pressure monitoring |
Amiloride Vascular Diseases Spironolactone Hypertension |
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