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

April 6, 2023 updated by: University of Minnesota

Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device

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

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univeristy of Minnesota Lillehei Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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
Arrhythmia group
LVAD patient with an irregular heartbeat.
Valvular disease group
LVAD patient with valvular heart disease
Normal control group
Healthy participant without any known heart disease (Control group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Observation of pulse wave signatures in LVAD patients
Time Frame: ongoing
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Peter Eckman, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 17, 2012

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA00000312-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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