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

NCT ID: NCT00204984

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-12-20

Brief Summary

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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

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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

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High Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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oral hydralazine and intravenous nesiritide

vasodilators

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Scios, Inc.

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy K Sweitzer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23537892 (View on PubMed)

Other Identifiers

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K23 AGO01022

Identifier Type: -

Identifier Source: secondary_id

H-2004-0382

Identifier Type: -

Identifier Source: org_study_id

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