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Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation

Primary Purpose

High Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oral hydralazine and intravenous nesiritide
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for High Blood Pressure focused on measuring arterial stiffness, echocardiography, nesiritide

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Wisconsin Hospital & Clinics

Outcomes

Primary Outcome Measures

heart myocardium relaxation (diastole)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
February 6, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Scios, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00204984
Brief Title
Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation
Official Title
The Effect of Aortic Impedance on Myocardial Relaxation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 20, 2006 (Actual)
Study Completion Date
December 20, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Scios, Inc.

4. Oversight

5. Study Description

Brief 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
Keywords
arterial stiffness, echocardiography, nesiritide

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oral hydralazine and intravenous nesiritide
Intervention Description
vasodilators
Primary Outcome Measure Information:
Title
heart myocardium relaxation (diastole)
Time Frame
before and after administration of vasodilator medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy K Sweitzer, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23537892
Citation
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.
Results Reference
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Heart and Blood Pressure Study: The Effect of Aortic Impedance on Myocardial Relaxation

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