Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation
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Purpose
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?
| Condition | Intervention |
|---|---|
|
High Blood Pressure |
Drug: oral hydralazine and intravenous nesiritide |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Effect of Aortic Impedance on Myocardial Relaxation |
- heart myocardium relaxation (diastole) [ Time Frame: before and after administration of vasodilator medication ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
-
Drug: oral hydralazine and intravenous nesiritide
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects over the age of 65
Exclusion Criteria:
- 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
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin Hospital & Clinics | |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: | Nancy K Sweitzer, MD, PhD | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | Nancy K. Sweitzer, MD PhD, University of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00204984 History of Changes |
| Other Study ID Numbers: | 2004-382, K23 AGO01022 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 15, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Wisconsin, Madison:
|
arterial stiffness echocardiography nesiritide |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydralazine Natriuretic Peptide, Brain Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Natriuretic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013