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Search / Trial NCT00430794

The Efficacy of Spironolactone in Patients With Resistant Hypertension

Launched by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST · Feb 1, 2007

Trial Information

Current as of July 21, 2025

Terminated

Keywords

Resistant Hypertension Spironolactone Double Blind Randomised Controlled Trial Ambulatory Blood Pressure Monitoring

ClinConnect Summary

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 hyperaldosteron...

Gender

ALL

Eligibility 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

About Sheffield Teaching Hospitals Nhs Foundation Trust

Sheffield Teaching Hospitals NHS Foundation Trust is a leading healthcare institution in the UK, dedicated to delivering high-quality patient care, advancing medical research, and fostering education and training in the health sector. As a prominent sponsor of clinical trials, the Trust collaborates with various stakeholders to facilitate innovative research initiatives that aim to improve treatment outcomes and enhance patient safety. With a commitment to excellence, the organization leverages its extensive clinical expertise and resources to support the development of new therapies and interventions, ultimately contributing to the advancement of healthcare practices both locally and globally.

Locations

Sheffield, South Yorkshire, United Kingdom

Patients applied

0 patients applied

Trial Officials

Peter R Jackson, MB ChB, PhD

Principal Investigator

University of Sheffield

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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