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| Sponsor: | VA Salt Lake City Health Care System |
|---|---|
| Information provided by: | VA Salt Lake City Health Care System |
| ClinicalTrials.gov Identifier: | NCT00709137 |
Purpose
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 |
|---|---|
|
Resistant Hypertension |
Drug: spironolactone Drug: amiloride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: 1
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)
|
Drug: spironolactone
tablet form. doses used range from 12.5-50mg po QDAY. Total duration would be until completion or study or medication intolerance.
|
|
Active Comparator: 2
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)
|
Drug: amiloride
amiloride 2.5-10 mg po QDAY. Duration until completion of study or until tolerance
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | Not yet recruiting |
| SLC, Utah, United States, 84148 | |
| Contact: Richard S Rose, MD 801-953-3004 richard.rose@hsc.utah.edu | |
| Contact: Amelia Underwood, MD amelia.underwood@va.gov | |
| Principal Investigator: Richard S Rose, MD | |
| Sub-Investigator: Barry Stults, MD | |
| Sub-Investigator: Amelia Underwood, MD | |
| Principal Investigator: | Richard S Rose, MD | Univ of Utah Division of General Internal Medicine; VAMC SLC Internal Medicine |
More Information
| Responsible Party: | Richard Rose, MD, VAMC SLC; University of Utah Division of General Internal Medicine |
| ClinicalTrials.gov Identifier: | NCT00709137 History of Changes |
| Other Study ID Numbers: | IRB_00027466 |
| Study First Received: | July 1, 2008 |
| Last Updated: | July 2, 2008 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
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resistant hypertensions spironolactone amiloride ambulatory blood pressure monitoring |
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Hypertension Vascular Diseases Cardiovascular Diseases Amiloride Spironolactone Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Diuretics Natriuretic Agents Physiological Effects of Drugs Aldosterone Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |