The Efficacy of Spironolactone in Patients With Resistant Hypertension

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: University of Sheffield
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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