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Completed

NCT Number: NCT00599235

Sildenafil and Exercise Capacity in Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh - Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study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

Treatment and study plan

Sildenafil

Drug

50mg 3 times daily for 7 days

Other names: Viagra

Hydralazine

Drug

25mg 3 times daily for 7 days

Placebo

Drug

3 times daily for 7 days

Primary outcomes

  1. Peak oxygen uptake (VO2) during exercise

    Time frame: 1 week of treatment

Secondary outcomes

  1. Exercise systolic blood pressure

    Time frame: Maximal exercise

  2. Pulse wave velocity and pulse wave analysis

    Time frame: Before and after maximal exercise

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Effects of the Selective Phosphodiesterase Type 5 Inhibitor Sildenafil Citrate on Exercise Capacity and Vascular Function in Hypertensive Subjects

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 23, 2008
Registry last updated
Apr 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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