NCT00970476

Brief Summary

To determine if arterial stiffness as measured by non-invasive pulse wave velocity can predict the response to resynchronization therapy in heart failure.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Status
withdrawn

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

January 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

5.5 years

First QC Date

September 1, 2009

Last Update Submit

August 28, 2012

Conditions

Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

  • If arterial stiffness can predict the response to resynchronization therapy in heart failure.

    6 months

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients, who are scheduled to undergo cardiac resynchronization therapy (CRT) at Creighton University Cardiac Center will be included in this study.

You may qualify if:

  • The patients receiving CRT are medically refractory, symptomatic, NYHA class III or IV disease and QRS duration of 130 m sec or greater, and a left ventricular ejection fraction of 30 percent or less.
  • All individuals are carefully selected after appropriate clinical evaluation as determined by the treating physicians to exclude possible reversible causes of heart failure.

You may not qualify if:

  • Patients with permanent atrial fibrillation and non-palpable carotid and/or femoral pulses will be excluded due to technical limitations of the procedure used for the measurement of arterial stiffness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Siva Sontineni, M.D.

    Creighton Cardiac Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

January 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 30, 2012

Record last verified: 2012-08