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The Efficacy of Spironolactone in Patients With Resistant Hypertension

This study has been terminated.
(Difficulties with recruitment.)
Sponsor:
Collaborator:
University of Sheffield
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00430794
First received: February 1, 2007
Last updated: December 3, 2010
Last verified: February 2007
  Purpose

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)


Condition Intervention Phase
Hypertension
Drug: Spironolactone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Placebo Controlled Trial of the Efficacy of the Addition of Spironolactone to Modern Antihypertensive Treatment Regimens in Patients With Resistant Hypertension

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • The primary endpoint will be the difference between the spironolactone and placebo groups in change in daytime average systolic blood pressure on ABPM from day 0 to day 42

Secondary Outcome Measures:
  • Difference between the spironolactone and placebo groups in change in daytime average diastolic blood pressure on ABPM from day 0 to day 42
  • Difference between the spironolactone and placebo groups in change in systolic and diastolic clinic blood pressure (mean of 2nd and 3rd readings) from day 0 to day 42
  • Difference between the spironolactone and placebo groups in change in serum creatinine from day 0 to day 42
  • Difference between the spironolactone and placebo groups in change in serum potassium from day 0 to day 42
  • Difference between the spironolactone and placebo groups in change in body weight from day 0 to day 42

Estimated Enrollment: 40
Study Start Date: March 2007
Study Completion Date: December 2008
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 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 hyperaldosteronism. Uncontrolled studies suggest that spironolactone is a very effective antihypertensive in the modern management of resistant hypertension but we could find no randomised trials in this setting. In the Sheffield Hypertension Clinic spironolactone is currently used as one of the drugs of choice in patients with resistant hypertension, particularly in women and is anecdotally often very effective.

Study methods. The study will be a double- blind randomised placebo controlled trial with a parallel group design assessing the addition of 25mg spironolactone to existing antihypertensive treatment, titrated to 50mg if necessary in 40 patients with resistant hypertension (20 patients per group) over a period of 6 weeks. Resistant hypertension will be defined as: 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. All patients' current antihypertensive treatment will include a thiazide diuretic and at least one of a beta-blocker, angiotensin converting enzyme inhibitor or angiotensin II receptor antagonist. The primary endpoint will be the difference between the spironolactone and placebo groups in change in daytime average systolic blood pressure on 24-hour ambulatory blood pressure monitoring from day 0 to day 42.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430794

Locations
United Kingdom
Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Investigators
Principal Investigator: Peter R Jackson, MB ChB, PhD University of Sheffield
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00430794     History of Changes
Other Study ID Numbers: STH14399
Study First Received: February 1, 2007
Last Updated: December 3, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
resistant hypertension
Spironolactone
double-blind
randomised controlled trial
ambulatory blood pressure monitoring

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Spironolactone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014