Official Title: “Effects of the Selective Phosphodiesterase Type 5 Inhibitor Sildenafil Citrate on Exercise Capacity and Vascular Function in Hypertensive Subjects”

Hypertension (persistently elevated blood pressure) is a major risk factor for heart disease and stroke. Hypertensive individuals show a reduced exercise capacity, which is present from a very early stage and contributes to their increased cardiovascular risk. Sildenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it works by enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases blood flow. We hypothesize that sildenafil, because of its effect on nitric oxide and blood flow, will improve exercise capacity in hypertensive patients. Therefore, the main aim of the study is to investigate the effects of PDE5 inhibition on exercise capacity and vascular function in hypertension, and to compare these effects in hypertensive patients and healthy controls.

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: sildenafil
  • 50mg 3 times daily for 7 days
• Drug: hydralazine
  • 25mg 3 times daily for 7 days
• Drug: placebo
  • 3 times daily for 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
• Other: 2

Primary Measures

• Peak oxygen uptake (VO2) during exercise
  • Time Frame: 1 week of treatment
    Safety Issue?: No

Secondary Measures

• Exercise systolic blood pressure
  • Time Frame: Maximal exercise
    Safety Issue?: No

Inclusion Criteria:

• Male (age range: 18 - 70 years)
• Appropriate blood pressure range
• Hypertensive - Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg
• Controls - Systolic BP <140 mmHg and diastolic BP <90mmHg
• Written informed consent

Exclusion Criteria:

• Female
• History of coronary artery, cerebrovascular or peripheral vascular disease within the last 6 months
• Total cholesterol >6.5 mmol/L
• Current alcohol abuse
• Diabetes mellitus
• Asthma
• Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study
• ECG evidence of clinically significant arrhythmia or cardiac ischaemia
• Clinically significant abnormality on screening blood test
• Contraindication to strenuous exercise
• Current involvement in other research projects
• Other clinically relevant conditions
• Lack of written informed consent

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Edinburgh

Overall Clinical Trial Officials and Contacts

Teresa M Attinà, MD Principal Investigator University of Edinburgh  

Overall Contact: Teresa M Attinà, MD +44 (0) 131 537 1826 tattina@ed.ac.uk

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00599235

Study ID Number: LREC/2004/4/13

ClinicalTrials.gov Identifier: NCT00599235

Health Authority: United Kingdom: Research Ethics Committee