Sildenafil and Exercise Capacity in Hypertension - Full Text View

Sponsored by:	University of Edinburgh
Information provided by:	University of Edinburgh
ClinicalTrials.gov Identifier:	NCT00599235

Purpose

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.

Condition	Intervention
Hypertension	Drug: sildenafil Drug: hydralazine Drug: placebo

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure

Drug Information available for: Hydralazine Sildenafil Sildenafil citrate Hydralazine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Official Title:	Effects of the Selective Phosphodiesterase Type 5 Inhibitor Sildenafil Citrate on Exercise Capacity and Vascular Function in Hypertensive Subjects

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:

Peak oxygen uptake (VO2) during exercise [ Time Frame: 1 week of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exercise systolic blood pressure [ Time Frame: Maximal exercise ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: sildenafil 50mg 3 times daily for 7 days Drug: hydralazine 25mg 3 times daily for 7 days Drug: placebo 3 times daily for 7 days
2	Drug: sildenafil 50mg 3 times daily for 7 days Drug: hydralazine 25mg 3 times daily for 7 days Drug: placebo 3 times daily for 7 days

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599235

Contacts

Contact: Teresa M Attinà, MD

+44 (0) 131 537 1826

tattina@ed.ac.uk

Locations

United Kingdom
University of Edinburgh - Western General Hospital	Recruiting
Edinburgh, United Kingdom, EH4 2XU
Principal Investigator: Teresa M Attinà, MD

Sponsors and Collaborators

University of Edinburgh

Investigators

Principal Investigator:	Teresa M Attinà, MD	University of Edinburgh
Study Director:	David J Webb, MD	University of Edinburgh

More Information

No publications provided

Responsible Party:	University of Edinburgh ( Marise Bucukoglu )
Study ID Numbers:	LREC/2004/4/13, LREC/2004/4/13
Study First Received:	January 7, 2008
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00599235 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:

Hypertension
Exercise capacity
PDE5 inhibitors

Study placed in the following topic categories:

Vasodilator Agents
Phosphodiesterase Inhibitors
Hydralazine
Citric Acid
Vascular Diseases

Sildenafil
Cardiovascular Agents
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hydralazine
Vascular Diseases
Sildenafil
Enzyme Inhibitors
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009