Response To Cardiac Resynchronization Therapy In Heart Failure: Role Of Arterial Stiffness

This study has been withdrawn prior to enrollment.
(limited enrollment)
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00970476
First received: September 1, 2009
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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


Condition
Arterial Stiffness

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Response To Cardiac Resynchronization Therapy In Heart Failure: Role Of Arterial Stiffness

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • If arterial stiffness can predict the response to resynchronization therapy in heart failure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

The pulse wave velocity between carotid and femoral (PWVcf) will be recorded in each subject at base line (before and after CRT), at one month (after AV delay optimization) and again at 6 months after CRT. The arterial pulse wave is recorded at a proximal artery, such as the carotid artery, and as well as at a distal artery, such as the femoral artery. The superficial location of the carotid and femoral arteries means that their pulse waveforms are readily measured noninvasively using the M Hz Doppler probe, and between these two sites the pulse wave has to travel through most of the aorta. The time delay between the arrival of a predefined part of the pulse wave, such as the foot, at these 2 points is obtained by gating to the peak of the R-wave of the ECG. The distance traveled by the pulse wave is measured over the body surface and PWV is then calculated as distance/time (m/s).

Clinical evidence of response: Either one or more of the following: 1) Improvement in NYHA functional classification, 2) Improvement in 6 minute walking distance. 3) Change in functional class, exercise tolerance while the heart is getting smaller on CXR. 4) Stabilization of patient CHF even without subjective improvement over 6 months (remaining class III rather than progressive to class IV). Imaging evidence of response: 1) Increase in left ventricular ejection fraction. 2) Reduction of mitral regurgitation. 3) Reduction of LV volume signifying reverse remodeling.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970476

Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Siva Sontineni, M.D. Creighton Cardiac Center
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00970476     History of Changes
Other Study ID Numbers: 06-14344
Study First Received: September 1, 2009
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014