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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204984
First Posted: September 20, 2005
Last Update Posted: October 5, 2015
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.
Collaborator:
Scios, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Aortic Impedance on Myocardial Relaxation

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

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

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)
Intervention Details:
    Drug: oral hydralazine and intravenous nesiritide
    vasodilators
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.
  Eligibility

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00204984


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204984     History of Changes
Other Study ID Numbers: 2004-382
K23 AGO01022
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: October 5, 2015
Last Verified: January 2009

Keywords provided by University of Wisconsin, Madison:
arterial stiffness
echocardiography
nesiritide

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