- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937570
Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT) (VAFRACT)
The Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity, a RAndomized Controlled Trial (VAFRACT)
Study Overview
Detailed Description
The use of Left Ventricular Assist Devices (LVAD) is a viable therapeutic option to improve survival and quality of life of patients with advanced and refractory heart failure (HF). However, after the implantation of an LVAD, patients' functional capacity (FC) is still reduced with maximum oxygen uptake (VO2 peak) values calculated at the cardiopulmonary exercise test (CPET) ranging from 11 to 20 ml/kg/min. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile, in particular for the right ventricle, and could provide an improvement on FC. VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by CPET in LVAD optimization free population.
The optimal device speed is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation associated or not to a dilatation of the right ventricle (RV). In this condition it is reasonable to expect a more favorable hemodynamic profile for the RV and a better response in terms of functional capacity.
Subjects studied are HF patients supported with a continuous-flow LVAD: HeartMate II (Thoratec Inc., Pleasanton, CA) and HeartMate 3 (HM 3, Abbott, North Chicago, IL). Patients are recruited from our Day Hospital of the Cardiac Surgery Department at the University Hospital of Verona.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Verona, Italy, 37126
- Department of Cardiac Surgery, University of Verona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least 3 months after LVAD implantation;
- compliance to the required follow-up schedule;
- age 18 or above or of legal age to give informed consent specific to state and national laws.
Exclusion Criteria:
- distance of less than 150 meters on the six-minute walk test (6MWT) or impossibility to perform CPET
- recent finding of any major device-related complication (sepsis, thrombosis …).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EO GROUP
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
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LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity).
The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle.
The recommended speed range varies according to the indications given in the data sheet for each specific device.
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No Intervention: CONTROL GROUP
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2 Peak
Time Frame: three months
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peak oxygen uptake measured by cardiopulmonary exercise test
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three months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With LVAD-related Hospitalizations
Time Frame: Three months
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Rate of hospitalizations for: device thrombosis, hemorrhagic events, infections, right heart failure, arrhythmias.
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Three months
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QoL: The EQ-5D Questionnaire
Time Frame: Three months
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Changes in quality of life perceived by EuroQoL (quality of life) Scale.
It is an instrument which evaluates the quality of life measuring with one question: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The answers given to these question (1 = no problems; 2 = some problems; 3 = extreme problems) are converted into EQ-5D index, an utility scores anchored at 0 for death and 1 for perfect health.
The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
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Three months
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Nt-proBNP
Time Frame: Three months
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Nt-proBNP levels
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Three months
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Right Ventricular Function
Time Frame: Three months
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Fractional area change of right ventricle assessed by echocardiography
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Three months
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CPET Exercise Time
Time Frame: Three months
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Cardiopulmonary exercise time
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Three months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MARZIA LILLIU, MD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1397CESC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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