The Efficacy of Spironolactone in Patients With Resistant Hypertension

NCT00430794 | Terminated Phase 2

• 1 other identifier: STH14399
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Hypertension

Keywords

resistant hypertension; Spironolactone; double-blind; randomised controlled trial; ambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

Spironolactone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Clinical Research Facility, Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Peter R Jackson, MB ChB, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 2, 2007
• Study Start: March 1, 2007
• Study Completion: December 1, 2008
• Last Updated: December 6, 2010

Record last verified: 2007-02

Locations

GB (1)