Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430794
Status:
TERMINATED
Last Update Posted:
2010-12-06
First Post:
2007-02-01
Brief Title:
The Efficacy of Spironolactone in Patients With Resistant Hypertension
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
A Randomised Placebo Controlled Trial of the Efficacy of the Addition of Spironolactone to Modern Antihypertensive Treatment Regimens in Patients With Resistant Hypertension
Status:
TERMINATED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties with recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the efficacy of the addition of spironolactone to modern blood pressure lowering treatment regimens in patients with resistant hypertension whose blood pressure is uncontrolled despite three blood pressure lowering drugs
Detailed Description:
Objective To assess the antihypertensive efficacy of adding spironolactone to the antihypertensive treatment of patients with resistant hypertension
Background and Rationale The proportion of hypertensive patients meeting the definition of resistant hypertension is growing rapidly as doctors use more combination antihypertensive treatments in order to reach lower target blood pressures Spironolactone is often used in specialist clinics for patients with resistant hypertension although it is currently only licensed in the UK for use in hypertension complicated by primary hyperaldosteronism Uncontrolled studies suggest that spironolactone is a very effective antihypertensive in the modern management of resistant hypertension but we could find no randomised trials in this setting In the Sheffield Hypertension Clinic spironolactone is currently used as one of the drugs of choice in patients with resistant hypertension particularly in women and is anecdotally often very effective
Study methods The study will be a double- blind randomised placebo controlled trial with a parallel group design assessing the addition of 25mg spironolactone to existing antihypertensive treatment titrated to 50mg if necessary in 40 patients with resistant hypertension 20 patients per group over a period of 6 weeks Resistant hypertension will be defined as blood pressures not adequately controlled systolic blood pressure SBP 140 mmHg andor diastolic blood pressure DBP 85 mmHg in clinic and on ambulatory blood pressure monitoring despite treatment with the maximum tolerated dose of three antihypertensive agents All patients current antihypertensive treatment will include a thiazide diuretic and at least one of a beta-blocker angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist The primary endpoint will be the difference between the spironolactone and placebo groups in change in daytime average systolic blood pressure on 24-hour ambulatory blood pressure monitoring from day 0 to day 42
Background and Rationale The proportion of hypertensive patients meeting the definition of resistant hypertension is growing rapidly as doctors use more combination antihypertensive treatments in order to reach lower target blood pressures Spironolactone is often used in specialist clinics for patients with resistant hypertension although it is currently only licensed in the UK for use in hypertension complicated by primary hyperaldosteronism Uncontrolled studies suggest that spironolactone is a very effective antihypertensive in the modern management of resistant hypertension but we could find no randomised trials in this setting In the Sheffield Hypertension Clinic spironolactone is currently used as one of the drugs of choice in patients with resistant hypertension particularly in women and is anecdotally often very effective
Study methods The study will be a double- blind randomised placebo controlled trial with a parallel group design assessing the addition of 25mg spironolactone to existing antihypertensive treatment titrated to 50mg if necessary in 40 patients with resistant hypertension 20 patients per group over a period of 6 weeks Resistant hypertension will be defined as blood pressures not adequately controlled systolic blood pressure SBP 140 mmHg andor diastolic blood pressure DBP 85 mmHg in clinic and on ambulatory blood pressure monitoring despite treatment with the maximum tolerated dose of three antihypertensive agents All patients current antihypertensive treatment will include a thiazide diuretic and at least one of a beta-blocker angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist The primary endpoint will be the difference between the spironolactone and placebo groups in change in daytime average systolic blood pressure on 24-hour ambulatory blood pressure monitoring from day 0 to day 42
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None