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Pulse Wave Analysis in Advanced Heart Failure (PWA-HF)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01642927
First received: July 12, 2012
Last updated: March 29, 2013
Last verified: March 2013
History of Changes
  Purpose

A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.


Condition
Left Ventricular Assist Device
Heart Failure
Intra-aortic Balloon Pump
LVAD Clot
LVAD-related GI Bleed

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Observation of pulse wave signatures in LVAD patients [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intra-Aortic Balloon Pump (IABP) Group
Advanced Heart Failure and/or pre-LVAD surgical patient with IABP
IABP/LVAD Group
Post-LVAD surgical patients with IABP
Post-LVAD Group
LVAD patients 3 months or greater post-implantation undergoing echocardiography
LVAD Event Group
LVAD patients who have developed LVAD thrombosis or GI hemorrhage related to LVAD

Detailed Description:

Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize:

  1. That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring.
  2. That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
  3. That clinical events involving LVAD will have characteristic frequency spectra.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Advanced heart failure patients, eligible for or currently treated with LVAD, outpatient cardiology clinic or inpatient heart failure service patients

Criteria

Inclusion Criteria:

1)18 years of age or older

2)Advanced heart failure as defined by need for IABP or LVAD

3)One or more of the following:

  • Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group

    •≤ 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group

    •≥ 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group

  • Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group

    4)Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

  1. Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups)
  2. Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642927

Locations
United States, Minnesota
Univeristy of Minnesota Lillehei Heart Institute
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Peter Eckman, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01642927     History of Changes
Other Study ID Numbers: University_of_Minnesota
Study First Received: July 12, 2012
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
LVAD
IABP
Heart Failure
Thrombosis
Hemorrhage

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Heart Failure
Gastrointestinal Diseases
Digestive System Diseases
 Hemorrhage
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013