EUCTR2006-004846-17-GB
Active, not recruiting
Not Applicable
A randomised, placebo controlled trial of the efficacy of the addition of spironolactone to modern antihypertensive treatment regimes in patients with resistant hypertension.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged\>18 years.
- •Hypertension (essential or secondary) managed in Sheffield Hypertension Clinic or General Practice or both.
- •Blood pressures not adequately controlled (SBP \>140 mmHg and/or DBP \>85 mmHg in clinic and on daytime mean ambulatory blood pressure monitoring) despite treatment with the maximum tolerated dose of 3 antihypertensive agents.
- •Additional antihypertensive treatment deemed appropriate by the patients' doctor.
- •Patients' current antihypertensive treatment includes a thiazide diuretic and a least one of: a beta blocker, angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist (i.e. modern antihypertensive regime where spironolactone is least likely to be effective).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Definite indication or contraindication for spironolactone.
- •Known Conn's syndrome.
- •Heart failure NYHA class III or IV.
- •Known hepatic failure or significant cirrhosis.
- •Known pregnancy or women planning pregnancy.
- •Women of child\-bearing potential not using adequate contraception methods.
- •Serum creatinine \>221 µmol/l.
- •Serum potassium \>5 mmol/l.
- •Clinic blood pressure or daytime ambulatory blood pressure \>240/120 mmHg.
Outcomes
Primary Outcomes
Not specified
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