PWA-HF: Pulse Wave Analysis in Advanced Heart Failure

Sponsor

University of Minnesota (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01642927

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Assist Device Heart Failure Intra-aortic Balloon Pump LVAD Clot LVAD-related GI Bleed

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:

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.
That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
That clinical events involving LVAD will have characteristic frequency spectra.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

Observation of pulse wave signatures in LVAD patients [ongoing]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.