Sildenafil and Exercise Capacity in Hypertension

NCT00599235 | Completed

• 1 other identifier: LREC/2004/4/13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Exercise capacity; PDE5 inhibitors

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake (VO2) during exercise

  1 week of treatment

Secondary Outcomes (2)

• Exercise systolic blood pressure

  Maximal exercise

• Pulse wave velocity and pulse wave analysis

  Before and after maximal exercise

Study Arms (2)

1

EXPERIMENTAL

Drug: sildenafil; Drug: hydralazine; Drug: placebo

2

ACTIVE COMPARATOR

Drug: sildenafil; Drug: hydralazine; Drug: placebo

Interventions

sildenafil DRUG

50mg 3 times daily for 7 days

Also known as: Viagra

1; 2

hydralazine DRUG

25mg 3 times daily for 7 days

1; 2

placebo DRUG

3 times daily for 7 days

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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• Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh - Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

Sildenafil Citrate; Hydralazine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phthalazines; Pyridazines

Study Officials

• Teresa M Attinà, MD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

• David J Webb, MD

  University of Edinburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 23, 2008
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 8, 2010

Record last verified: 2008-01

Locations

GB (1)