Status:
TERMINATED
The Efficacy of Spironolactone in Patients With Resistant Hypertension
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
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 hype...
Eligibility Criteria
Inclusion
- Aged over 18 years
- Hypertension (essential or secondary) managed in Sheffield Hypertension Clinic or general practice or both.
- Blood pressures not adequately controlled (systolic blood pressure (SBP) \>140 mmHg and/or 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.
- Additional antihypertensive treatment deemed appropriate by the patients' doctor.
- Patients' current antihypertensive treatment includes a thiazide diuretic and at least one of a beta-blocker, angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist.
Exclusion
- Definite indication or contraindication for spironolactone
- Known Conn's syndrome (definite indication for spironolactone)
- Heart failure NYHA class III or IV (definite indication for spironolactone)
- Known hepatic failure or significant cirrhosis
- Known pregnancy or women planning pregnancy
- Women of child bearing potential not using adequate contraceptive methods
- Serum creatinine \> 221µmol/l
- Serum Potassium \> 5.0mmol/l
- Clinic blood pressure or daytime ambulatory blood pressure \>240/120
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00430794
Start Date
March 1 2007
End Date
December 1 2008
Last Update
December 6 2010
Active Locations (1)
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1
Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF