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Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT) (VAFRACT)

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ClinicalTrials.gov Identifier: NCT03937570
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Marzia Lilliu, Universita di Verona

Brief Summary:
After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable hemodynamic profile and could provide an improvement on functional capacity (FC). VAFRACT is a prospective randomized trial to evaluate the additional benefit of an EO approach on FC, measured by cardiopulmonary exercise test (CPET), in LVAD optimization free population.

Condition or disease Intervention/treatment Phase
Heart Failure Device: echo-optimization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity, a RAndomized Controlled Trial (VAFRACT)
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: EO GROUP
Patients underwent LVAD echo-optimization; the optimal device speed is confirmed at the end of procedure.
Device: echo-optimization
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.

No Intervention: CONTROL GROUP
Patients underwent LVAD echo-optimization, but the optimal device speed is not confirmed at the end of procedure.



Primary Outcome Measures :
  1. VO2 peak [ Time Frame: three months ]
    peak oxygen uptake measured by cardiopulmonary exercise test


Secondary Outcome Measures :
  1. LVAD-related hospitalizations [ Time Frame: Three months ]
    Rate of hospitalizations for: device thrombosis, hemorrhagic events, infections, right heart failure, arrhythmias.

  2. QoL: The EQ-5D questionnaire [ Time Frame: Three months ]
    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).

  3. Nt-proBNP [ Time Frame: Three months ]
    Nt-proBNP levels

  4. Right ventricular function [ Time Frame: Three months ]
    Fractional area change of right ventricle assessed by echocardiography

  5. CPET exercise time [ Time Frame: Three months ]
    Cardiopulmonary exercise time



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 …).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937570


Contacts
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Contact: MARZIA LILLIU, MD +393281383539 marzialilliu@gmail.com

Locations
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Italy
Department of Cardiac Surgery, University of Verona Recruiting
Verona, Italy, 37126
Contact: MARZIA LILLIU, MD    +393281383539    marzialilliu@gmail.com   
Sponsors and Collaborators
Universita di Verona
Investigators
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Principal Investigator: MARZIA LILLIU, MD
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Responsible Party: Marzia Lilliu, MD, Principal Investigator, PhD student in Cardiovascular Sciences, Universita di Verona
ClinicalTrials.gov Identifier: NCT03937570    
Other Study ID Numbers: 1397CESC
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Marzia Lilliu, Universita di Verona:
left ventricular assist device
echo-optimization
functional capacity
cardiopulmonary exercise test
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases