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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204984
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 5, 2015
Scios, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

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?

Condition or disease Intervention/treatment Phase
High Blood Pressure Drug: oral hydralazine and intravenous nesiritide Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Aortic Impedance on Myocardial Relaxation
Study Start Date : May 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: oral hydralazine and intravenous nesiritide

Primary Outcome Measures :
  1. heart myocardium relaxation (diastole) [ Time Frame: before and after administration of vasodilator medication ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204984

United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Scios, Inc.
Principal Investigator: Nancy K Sweitzer, MD, PhD University of Wisconsin, Madison

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison Identifier: NCT00204984     History of Changes
Other Study ID Numbers: 2004-382
K23 AGO01022
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: January 2009

Keywords provided by University of Wisconsin, Madison:
arterial stiffness

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents