HypertensionNCT00599235
Sildenafil and Exercise Capacity in Hypertension
A study testing sildenafil and hydralazine in people with Hypertension, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- sildenafil and hydralazine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study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 locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh - Western General Hospital
Edinburgh, EH4 2XU
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- sildenafil, hydralazine, placebo
- Keywords
- Hypertension, Exercise capacity, PDE5 inhibitors
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Also called Viagra
50mg 3 times daily for 7 days
hydralazineDrug
25mg 3 times daily for 7 days
placeboDrug
3 times daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: sildenafil; Drug: hydralazine; Drug: placebo |
| 2 | Active comparator | Not described Receives: Drug: sildenafil; Drug: hydralazine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2) during exercise
Measured: 1 week of treatment
Secondary outcomes (2)
Exercise systolic blood pressure
Measured: Maximal exercise
Pulse wave velocity and pulse wave analysis
Measured: Before and after maximal exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startMar 2007
- Primary completionMay 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Investigators
- Teresa M Attinà, MD, Principal investigator, University of EdinburghDavid J Webb, MD, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599235
- Sponsor's protocol ID
- LREC/2004/4/13
- Other IDs
- LREC/2004/4/13
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 8 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Selective Phosphodiesterase Type 5 Inhibitor Sildenafil Citrate on Exercise Capacity and Vascular Function in Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT00599235
- Acronym / sponsor ID
- LREC/2004/4/13
- Conditions
- Hypertension
- Keywords
- Hypertension, Exercise capacity, PDE5 inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: sildenafil, Drug: hydralazine, Drug: placebo |
| 2 | Active comparator | Drug: sildenafil, Drug: hydralazine, Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafilAlso: Viagra50mg 3 times daily for 7 days | Drug | 1, 2 |
| hydralazine25mg 3 times daily for 7 days | Drug | 1, 2 |
| placebo3 times daily for 7 days | Drug | 1, 2 |
Primary outcome
Peak oxygen uptake (VO2) during exercise
Time frame: 1 week of treatment
2 secondary outcomes
Exercise systolic blood pressure
Time frame: Maximal exercise
Pulse wave velocity and pulse wave analysis
Time frame: Before and after maximal exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa M Attinà, MD principal investigator
University of Edinburgh
David J Webb, MD study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sildenafil and hydralazine in people with Hypertension, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (VO2) during exercise (time frame: 1 week of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2010; AzTrials last refreshed its copy on 1 Nov 2026.