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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00204984
Other study ID # H-2004-0382
Secondary ID K23 AGO01022
Status Completed
Phase N/A
First received
Last updated
Start date May 2005
Est. completion date December 20, 2006

Study information

Verified date February 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date December 20, 2006
Est. primary completion date December 20, 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
oral hydralazine and intravenous nesiritide
vasodilators

Locations

Country Name City State
United States University of Wisconsin Hospital & Clinics Madison Wisconsin

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison Scios, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary heart myocardium relaxation (diastole) before and after administration of vasodilator medication
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