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

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204984
First received: September 13, 2005
Last updated: January 15, 2009
Last verified: January 2009
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Wisconsin, Madison

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy K. Sweitzer, MD PhD, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00204984     History of Changes
Other Study ID Numbers: 2004-382, K23 AGO01022
Study First Received: September 13, 2005
Last Updated: January 15, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 26, 2014