HealthyNCT00182923
Forearm Vascular Relaxation
An observational study of Healthy, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Dec 2006
- Phase
- Observational
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal physical status without any medical interventions or agents which would alter the defined status of normal
Who cannot join
- Age less than 21 or greater than 45
- Unable to give informed consent
- BMI (Body Mass Index) less than 18 or greater than 25
- Clinically significant abnormal laboratory values
- Abnormal physical exam
- Abnormal EKG
Show all 11Show fewer
- Pregnancy
- Smoking or drug usage (illicit or otherwise)
- Post-menopause
- Participation in another clinical trial in the past month
- Chronic Illness
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Aging (NIA), Harbor Hospital
Baltimore, Maryland, 21225
About this study
Official title: Determinants of Forearm Vascular Relaxation: Role of Genetic Polymorphisms
The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs
Read the detailed description
Differences in at least 4 genes are believed to have an important effect on responses to hormones and drugs. For this study, healthy volunteers of normal body weight will be screened to find xxx individuals with the genes of interest. Very small doses of hormones and drugs will be given so that changes in forearm blood flow can be measured, while not causing effects throughout the body. A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm. Forearm blood flow is determined by the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and below arterial blood pressure). The hormones and drugs being studied include angiotensin I, angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine, endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process will be repeated with the same participant over 2 weeks later.
- Conditions
- Healthy
- Keywords
- Blood pressure, genetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Darrell R. Abernethy, MD, PhD, Principal investigator, National Institute on Aging, Laboratory of Clinical Investigation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182923
- Sponsor's protocol ID
- AG0038
- Status last verified
- Aug 2008
- First submitted
- 12 Sep 2005
- Last updated
- 29 Aug 2008
- Results posted
- No
Publications
Abernethy DR, Laurie N, Andrawis NS. Local angiotensin-converting enzyme inhibition blunts endothelin-1-induced increase in forearm vascular resistance. Clin Pharmacol Ther. 1995 Sep;58(3):328-34. doi: 10.1016/0009-9236(95)90250-3.
PubMed 7554707Abernethy DR, Winterbottom LM. Forearm vascular alpha 1-adrenergic blockade by verapamil. Clin Pharmacol Ther. 1990 Jun;47(6):755-9. doi: 10.1038/clpt.1990.104.
PubMed 2162750Andrawis NS, Craft N, Abernethy DR. Calcium antagonists block angiotensin II-mediated vasoconstriction in humans: comparison with their effect on phenylephrine-induced vasoconstriction. J Pharmacol Exp Ther. 1992 Jun;261(3):879-84.
PubMed 1602392
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Forearm Vascular Relaxation: Role of Genetic Polymorphisms
- ClinicalTrials.gov ID
- NCT00182923
- Acronym / sponsor ID
- AG0038
- Conditions
- Healthy
- Keywords
- Blood pressure, genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- May 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Sep 2005 (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.
The purpose of this study is to learn the effect of inherited differences on forearm blood flow responses to hormones and drugs
Detailed description
Differences in at least 4 genes are believed to have an important effect on responses to hormones and drugs. For this study, healthy volunteers of normal body weight will be screened to find xxx individuals with the genes of interest. Very small doses of hormones and drugs will be given so that changes in forearm blood flow can be measured, while not causing effects throughout the body. A brachial artery line and venous line will be placed in the study arm so that blood samples may be withdrawn to compare amounts given into the artery and coming out of the vein after circulating through the arm. Forearm blood flow is determined by the rate of swelling of the arm after a blood pressure cuff is inflated (above venous and below arterial blood pressure). The hormones and drugs being studied include angiotensin I, angiotensin II, acetylcholine, sodium nitroprusside, enalaprilat, L-arginine, phenylephrine, endothelin-1, verapamil, and isoproterenol. This procedure will last 4-6 hours. The process will be repeated with the same participant over 2 weeks later.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal physical status without any medical interventions or agents which would alter the defined status of normal
Key exclusion criteria (11 listed)
- Age less than 21 or greater than 45
- Unable to give informed consent
- BMI (Body Mass Index) less than 18 or greater than 25
- Clinically significant abnormal laboratory values
- Abnormal physical exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Aug 2008.
- Background: PubMed 7554707Abernethy DR, Laurie N, Andrawis NS. Local angiotensin-converting enzyme inhibition blunts endothelin-1-induced increase in forearm vascular resistance. Clin Pharmacol Ther. 1995 Sep;58(3):328-34. doi: 10.1016/0009-9236(95)90250-3.
- Background: PubMed 2162750Abernethy DR, Winterbottom LM. Forearm vascular alpha 1-adrenergic blockade by verapamil. Clin Pharmacol Ther. 1990 Jun;47(6):755-9. doi: 10.1038/clpt.1990.104.
- Background: PubMed 1602392Andrawis NS, Craft N, Abernethy DR. Calcium antagonists block angiotensin II-mediated vasoconstriction in humans: comparison with their effect on phenylephrine-induced vasoconstriction. J Pharmacol Exp Ther. 1992 Jun;261(3):879-84.
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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.
Darrell R. Abernethy, MD, PhD principal investigator
National Institute on Aging, Laboratory of Clinical Investigation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Institute on Aging (NIA) 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 11 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 29 Aug 2008. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182923, which also lists 3 linked publications.
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 29 Aug 2008.