Heart DiseasesNCT00005117
Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal
A study testing pravastatin in people with Heart Diseases, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. Although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- pravastatin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No history of the following: hypertension, diabetes mellitus, smoking, and coronary artery disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
4200 E. 9th Avenue, Box B133
Denver, Colorado, 80262
About this study
There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. Although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. It has also been shown that consumption of a fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These subjects will be randomly assigned to initially receive four days of pravastatin or an inactive substance, and then crossed over to the other group. Blood vessel functioning will be monitored by a technique called flow mediated vasoactivity, which uses ultrasound measurement of the forearm artery and its response to temporary occlusion. This primary measure of flow mediated vasoactivity will be done before and after consumption of a fatty meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction known to occur after a high fat meal. Secondary outcomes will include measurement of endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead to further studies about their use in more acute medical settings, including heart attacks or strokes.
- Conditions
- Heart Diseases
- Being tested
- pravastatin
- Keywords
- endothelial dysfunction
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pravastatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2000 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005117
- Sponsor's protocol ID
- NCRR-M01RR00051-1162
- Other IDs
- M01RR000051
- Status last verified
- Nov 2001
- First submitted
- 18 Apr 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal
- ClinicalTrials.gov ID
- NCT00005117
- Acronym / sponsor ID
- NCRR-M01RR00051-1162
- Conditions
- Heart Diseases
- Keywords
- endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 19 Apr 2000 (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.
There is significant evidence that HMG-CoA reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. Although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. It has also been shown that consumption of a fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. This study will examine if pravastatin, an HMG-CoA reductase inhibitor, improves blood vessel functioning after a fatty meal. We plan on enrolling 32 subjects, aged 18-40 years, who are healthy with no history of diabetes, smoking, high blood pressure, or heart disease. These subjects will be randomly assigned to initially receive four days of pravastatin or an inactive substance, and then crossed over to the other group. Blood vessel functioning will be monitored by a technique called flow mediated vasoactivity, which uses ultrasound measurement of the forearm artery and its response to temporary occlusion. This primary measure of flow mediated vasoactivity will be done before and after consumption of a fatty meal. We hope to show that treatment with pravastatin prevents the blood vessel dysfunction known to occur after a high fat meal. Secondary outcomes will include measurement of endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid profiles. If pravastatin does prevent endothelial dysfunction in this setting, it could lead to further studies about their use in more acute medical settings, including heart attacks or strokes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No history of the following: hypertension, diabetes mellitus, smoking, and coronary artery disease
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| pravastatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pravastatin in people with Heart Diseases, run by National Center for Research Resources (NCRR) at 1 site in United States.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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 States. 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?
Results are not available in the source record.
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.
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 24 Jun 2005.