NCT00204984

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2006

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

September 13, 2005

Last Update Submit

February 6, 2019

Conditions

High Blood Pressure

Keywords

arterial stiffnessechocardiographynesiritide

Outcome Measures

Primary Outcomes (1)

  • heart myocardium relaxation (diastole)

    before and after administration of vasodilator medication

Interventions

oral hydralazine and intravenous nesiritideDRUG

vasodilators

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjects over the age of 65

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • 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.

    PMID: 23537892RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Hydralazine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhthalazinesPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nancy K Sweitzer, MD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

May 1, 2005

Primary Completion

December 20, 2006

Study Completion

December 20, 2006

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

US(1)