Sildenafil and Exercise Capacity in Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Drug: sildenafil; Drug: hydralazine; Drug: placebo

• Registration Number: NCT00599235
• Lead Sponsor: University of Edinburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Status Verified: 2008-01
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-23
• Primary Completion: 2008-05
• Study Completion: 2008-08
• Last Update Submitted: 2010-04-07
• Last Update Posted: 2010-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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• Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	sildenafil	-
1	hydralazine	-
1	placebo	-
2	sildenafil	-
2	hydralazine	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake (VO2) during exercise	1 week of treatment

Secondary Outcome Measures

Name	Time	Method
Exercise systolic blood pressure	Maximal exercise
Pulse wave velocity and pulse wave analysis	Before and after maximal exercise

Trial Locations

Locations (1)

University of Edinburgh - Western General Hospital; 🇬🇧 Edinburgh, United Kingdom