Sildenafil and Exercise Capacity in Hypertension

University of Edinburgh

Status: Completed

Conditions: Hypertension

Treatments: Drug: hydralazine; Drug: placebo; Drug: sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT00599235

LREC/2004/4/13

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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• Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study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

Trial design

30 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: hydralazine

Drug: sildenafil

Drug: placebo

2

Active Comparator group

Treatment:

Drug: hydralazine

Drug: sildenafil

Drug: placebo