High Blood PressureNCT00204984
Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation
A study testing oral hydralazine and intravenous nesiritide in people with High Blood Pressure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness? Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- oral hydralazine and intravenous nesiritide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to 20 Dec 2006
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects over the age of 65
Who cannot join
- Have known or suspected coronary artery disease
- Have known or suspected left ventricular dysfunction
- Have significant valvular, infiltrative, pericardial, or congenital heart disease
- Have a resting systolic blood pressure < 100 mmHg
- Have had an adverse reaction to nesiritide or hydralazine
- Have a serum creatinine > 2 mg/dl at Visit 1
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
About this study
Official title: The Effect of Aortic Impedance on Myocardial Relaxation
Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness?
Read the detailed description
60 subjects, 30 with hypertension and 30 without will attend two visits to the GCRC. At each visit, pulsatile hemodynamics (by using tonometry-a non-invasive means to obtain arterial pressure tracings) and Doppler tissue imaging relaxation velocity (a measurement of myocardial relaxation obtained by echocardiography) data will be collected before and after administration of vasodilator medication. At the first visit, each patient will receive an oral dose of the vasodilator hydralazine (does not effect aortic stiffness), and at the second visit each patient will receive intravenous nesiritide (does effect aortic stiffness). The relationship between timing of the reflected pulse wave and myocardial relaxation velocity will be studied at baseline and following administration of each vasodilator to determine if changing aortic stiffness has an impact on myocardial relaxation.
- Conditions
- High Blood Pressure
- Being tested
- oral hydralazine and intravenous nesiritide
- Keywords
- arterial stiffness, echocardiography, nesiritide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral hydralazine and intravenous nesiritideDrug
vasodilators
What is being measured
The primary outcome is the main question the study is designed to answer.
heart myocardium relaxation (diastole)
Measured: before and after administration of vasodilator medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2005
- Primary completion20 Dec 2006
- Study completion20 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Scios, Inc.
- Responsible party
- Sponsor
- Investigators
- Nancy K Sweitzer, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204984
- Sponsor's protocol ID
- H-2004-0382
- Other IDs
- K23 AGO01022
- Status last verified
- Feb 2019
- First submitted
- 13 Sep 2005
- Last updated
- 8 Feb 2019
- Results posted
- No
Publications
Sweitzer NK, Hetzel SJ, Skalski J, Velez M, Eggleston K, Mitchell GF. Left ventricular responses to acute changes in late systolic pressure augmentation in older adults. Am J Hypertens. 2013 Jul;26(7):866-71. doi: 10.1093/ajh/hpt043. Epub 2013 Mar 28.
PubMed 23537892
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aortic Impedance on Myocardial Relaxation
- ClinicalTrials.gov ID
- NCT00204984
- Acronym / sponsor ID
- H-2004-0382
- Conditions
- High Blood Pressure
- Keywords
- arterial stiffness, echocardiography, nesiritide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Scios, Inc.
- Study start
- May 2005
- Primary completion
- 20 Dec 2006 (actual)
- Study completion
- 20 Dec 2006 (actual)
- First posted
- 20 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.
Does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness?
Detailed description
60 subjects, 30 with hypertension and 30 without will attend two visits to the GCRC. At each visit, pulsatile hemodynamics (by using tonometry-a non-invasive means to obtain arterial pressure tracings) and Doppler tissue imaging relaxation velocity (a measurement of myocardial relaxation obtained by echocardiography) data will be collected before and after administration of vasodilator medication. At the first visit, each patient will receive an oral dose of the vasodilator hydralazine (does not effect aortic stiffness), and at the second visit each patient will receive intravenous nesiritide (does effect aortic stiffness). The relationship between timing of the reflected pulse wave and myocardial relaxation velocity will be studied at baseline and following administration of each vasodilator to determine if changing aortic stiffness has an impact on myocardial relaxation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Subjects over the age of 65
Key exclusion criteria (6 listed)
- Have known or suspected coronary artery disease
- Have known or suspected left ventricular dysfunction
- Have significant valvular, infiltrative, pericardial, or congenital heart disease
- Have a resting systolic blood pressure < 100 mmHg
- Have had an adverse reaction to nesiritide or hydralazine
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 |
|---|---|---|
| oral hydralazine and intravenous nesiritidevasodilators | Drug | – |
Primary outcome
heart myocardium relaxation (diastole)
Time frame: before and after administration of vasodilator medication
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 Feb 2019.
- Results publication: PubMed 23537892Sweitzer NK, Hetzel SJ, Skalski J, Velez M, Eggleston K, Mitchell GF. Left ventricular responses to acute changes in late systolic pressure augmentation in older adults. Am J Hypertens. 2013 Jul;26(7):866-71. doi: 10.1093/ajh/hpt043. Epub 2013 Mar 28.
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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.
Nancy K Sweitzer, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral hydralazine and intravenous nesiritide in people with High Blood Pressure, run by University of Wisconsin, Madison 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 6 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 Feb 2019. 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.
What does the primary outcome measure?
heart myocardium relaxation (diastole) (time frame: before and after administration of vasodilator medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00204984, which also lists 1 linked publication.
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 Feb 2019.