A randomised, placebo controlled trial of the efficacy of the addition of spironolactone to modern antihypertensive treatment regimes in patients with resistant hypertension.

• Conditions: Resistant hypertension.; MedDRA version: 8.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2006-004846-17-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified