Sildenafil and Exercise Capacity in Hypertension

April 7, 2010 updated by: University of Edinburgh

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • University of Edinburgh - Western General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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  • Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: sildenafil
50mg 3 times daily for 7 days
Other Names:
  • Viagra
Drug: hydralazine
25mg 3 times daily for 7 days
Drug: placebo
3 times daily for 7 days
EXPERIMENTAL: 1
Drug: sildenafil
50mg 3 times daily for 7 days
Other Names:
  • Viagra
Drug: hydralazine
25mg 3 times daily for 7 days
Drug: placebo
3 times daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peak oxygen uptake (VO2) during exercise
Time Frame: 1 week of treatment
1 week of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise systolic blood pressure
Time Frame: Maximal exercise
Maximal exercise
Pulse wave velocity and pulse wave analysis
Time Frame: Before and after maximal exercise
Before and after maximal exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Investigators

  • Principal Investigator: Teresa M Attinà, MD, University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 10, 2008

First Posted (ESTIMATE)

January 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2010

Last Update Submitted That Met QC Criteria

April 7, 2010

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LREC/2004/4/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on sildenafil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe